| Standard Body | Number | Title | Summary | Link |
|---|---|---|---|---|
| AAMI | TIR12 | Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers | This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annexes. | Visit link >> |
| AAMI/IEC | 60601 | Medical electrical equipment - General requirements for basic safety and performance | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance is the third edition of the standard that covers any medical device that requires an electrical outlet or a battery. It has come to be known throughout the industry as the "bible" of medical electrical equipment standards. | Visit link >> |
| ANSI | 75:2009 | The HFE process for medical device design and evaluation is discussed in detail in ANSI/AAMI HE74:2001/(R)2009, Human factors design process for medical devices, and in comparable international standards. | HFE is not blind adherence to a set of guidelines; it is the sum of several processes:
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| ANSI | 12 | The purpose of this standard is to provide minimum requirements for the design, construction, and marking of electrical equipment or parts of such equipment for use in Class I and Class II, Division 2 and Class III, Divisions 1 and 2 hazardous (classified) locations. | NA | Visit link >> |
| ANSI/AAMI | EC12 | Disposable ECG Electrodes | Establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiography (ECG) or ECG monitoring | Visit link >> |
| ANSI/AAMI | ST77 | Containment devices for reusable medical device sterilization | The objectives of AAMI's technical development program derive from AAMI's overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. | Visit link >> |
| ASTM | F1980 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices | Stability testing shall demonstrate that the sterile barrier system maintains integrity over time. Stability testing using accelerated aging protocols shall be regarded as sufficient evidence for claimed expiry date until data from real time aging studies are available. | Visit link >> |
| ASTM | F1140 / F1140M | Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages | This test provides a rapid means of evaluating tendencies for package seal failure when the package is exposed to a pressure differential. Pressure differentials may occur during such processes as sterilization and transportation. This test method provides an indicator of the burst strength of a package, where the burst will normally occur in one or more areas of the seal. An indicator of the minimum burst strength may be of importance to the package manufacturer and end user in ensuring adequate package integrity. This test method cannot provide a measure of package seal uniformity. This test method also cannot provide an evaluation of overall package integrity or the burst strength of areas of the package that contact the surface of the restraining plates used. This test method should be combined with other methods of evaluating overall package integrity, uniformity of the package seal, or opening functionality, if so required. | Visit link >> |
| ASTM | F2054 / F2054M | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates | Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates | Visit link >> |
| ASTM | D4332 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing , conditioning, conditions, containers, environment | ASTM-D4332 provides for conditioning atmospheres that are used prior to conducting transit simulation tests. | Visit link >> |
| ASTM | D4169 | D4169 - 16 Standard Practice for Performance Testing of Shipping Containers and Systems , compression test, distribution cycle, distribution environment | This practice provides a uniform basis of evaluating, in a laboratory, the ability of shipping units to withstand the distribution environment | Visit link >> |
| ASTM | F88 / F88M | Standard Test Method for Seal Strength of Flexible Barrier Materials. | This test method covers the measurement of the strength of seals in flexible barrier materials. | Visit link >> |
| ASTM | F1929 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them. | Visit link >> |
| ASTM | F2096 | Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) | The internal pressurization test method provides a practical way to examine packages for gross leaks. | Visit link >> |
| ASTM | F1886 / F1886M | Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | This test method covers the determination of channels in the package seal down to a width of 75 µm [0.003 in.] with a 60–100?% probability | Visit link >> |
| ASTM | E515 | Standard Practice for Leaks Using Bubble Emission Techniques , bubble leak testing, film solution leak test, immersion leak test, leak testing | This practice covers procedures for detecting or locating leaks, or both, by bubble emission techniques. A quantitative measure is not practical. The normal limit of sensitivity for this test method is 4.5?×?10-10 mol/s (1?×?10-5 Std cm3/s).2 | Visit link >> |
| ASTM | D642 | Standard Test Method for Determining Compressive Resistance of Shipping Containers, Components, and Unit Loads | This test method covers compression tests on shipping containers (for example, boxes and drums) or components, or both. Shipping containers may be tested with or without contents. The procedure may be used for measuring the ability of the container to resist external compressive loads applied to its faces, to diagonally opposite edges, or to corners | Visit link >> |
| ASTM | D5276 | Standard Test Method for Drop Test of Loaded Containers by Free Fall | This test method covers procedures for the drop testing of loaded boxes, cylindrical containers, and bags and sacks by the free-fall method. | Visit link >> |
| ASTM | D4728 | Standard Test Method for Random Vibration Testing of Shipping Containers | This test method covers the random vibration testing of filled shipping units. Such tests may be used to assess the performance of a container with its interior packing and means of closure in terms of its ruggedness and the protection that it provides the contents when subjected to random vibration inputs. | Visit link >> |
| ASTM | D999 | Standard Test Methods for Vibration Testing of Shipping Containers | These test methods cover vibration tests of filled shipping containers. Such tests may be used to assess the performance of a container, with its interior packing and means of closure, both in terms of its strength and of the protection it provides its contents when it is subjected to vibration such as it experiences in transportation. These procedures are suitable for testing containers of any form, material, kind, design of interior packing, means of closure, and any size and weight. They are not intended for determining the response of products to vibration for product design purposes, nor are they intended for tests of products in their operational configuration as other more suitable procedures are available for these purposes. | Visit link >> |
| ASTM | E2314 | Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test) | This test method is written principally for large medical instruments or instruments with internal channels or recesses (for example, flexible endoscopes) but may be used for any resuable medical instruments. | Visit link >> |
| ASTM | E1837 | Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices (Simulated Use Test) | This test method is intended to describe a procedure for testing the effectiveness of a disinfection process for reprocessing reusable medical devices when it is tested with a challenge of vegetative cells including mycobacteria. Disinfection normally deals with testing activity against vegetative cells of bacteria, viruses, and fungi. Since this test method is process oriented, the user may wish to examine a variety of test organisms. | Visit link >> |
| DIN | 58953-6 | Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized | Microbial barrier testing of packaging materials for medical devices which are to be sterilized | Visit link >> |
| EN | 868-2 | Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods | This standard provides test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. | Visit link >> |
| EN | 868-5 | Packaging for terminally sterilized medical devices | Part 1 of the BS EN 868 series of European standards specifies general requirements and test methods for all packaging materials and systems intended for use as packaging for medical devices which are to be terminally sterilized in their packaging. | Visit link >> |
| EN | 22248 | Packaging; complete, filled transport packages; vertical impact test by dropping (ISO 2248:1985); german version EN 22248:1992 | NA | Visit link >> |
| EN | 868-8 | Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. | Performance, Sterilization (hygiene), Design, Marking, Ageing tests, Consumer-supplier relations, Closures, Handles, Life (durability), Packaging, Medical equipment, Weight measurement, Strength of materials, Visual inspection (testing), Instructions for use, Stacking tests, Holes, Packaging materials, Sterile equipment, Steam, Medical instruments, Packages, Mechanical testing, Re-usable packages, Performance testing, Load capacity, Dimensions, Containers, Lids | Visit link >> |
| EN | 285 | Sterilisation – Steam Sterilisers – Large Sterilisers | EN 285 provides general performance specifications for small steam sterilisers along with schedules for manufacturer type tests and works tests. | Visit link >> |
| EN | 45502-2-3 | Active implantable medical devices. Particular requirements for cochlear and auditory brainstem implant systems | Implants (surgical), Prosthetic devices, Medical equipment, Electrical medical equipment, Hearing aids, Brain, Ears, Neural stimulators, Surgical equipment, Signal generators, Electrical impedance, Electrodes, Environmental testing, Test equipment, Testing conditions | Visit link >> |
| EN | 1616 | Sterile urethral catheters for single use (includes Amendment A1:1999) | NA | Visit link >> |
| EN | 1618 | Catheters other than intravascular catheters. Test methods for common properties | Catheters, Cannulas, Medical instruments, Medical equipment, Corrosion tests, Tensile testing, Mechanical testing, Leak tests, Pressure testing, Flow rates, Flow measurement, Test equipment, Testing conditions, Specimen preparation | Visit link >> |
| EN | 13868 | Catheters. Test methods for kinking of single lumen catheters and medical tubing | Bending, Tubing (medical), Medical instruments, Flexural strength, Medical equipment, Bend testing, Catheters | Visit link >> |
| EN | 12342 (Currently Withdrawn) | Breathing tubes intended for use with anaesthetic apparatus and ventilators | Breathing apparatus, Medical breathing apparatus, Anaesthetic equipment, Medical equipment, Dimensions, Length, Pipe connections, Flow rates, Valves, Leak tests, Flow measurement, Conformity, Instructions for use, Electrical resistance, Sterile equipment, Packaging, Marking, Air, Bend testing, Approval testing, Test equipment | Visit link >> |
| IEC | 62366 | Medical devices - Part 1: Application of usability engineering to medical devices | Specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY | Visit link >> |
| IEC | 60335-2 | Household and similar electrical appliances - Safety - Part 2-12: Particular requirements for warming plates and similar appliances | Deals with the safety of electric oral hygiene appliances for households and similar purposes, their rated voltage being not more than 250 V. Examples of appliances covered by this standard are oral irrigators and tooth brushes | Visit link >> |
| IEC/ISO | 80369-1 | Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements | ISO 80369-1:2010 specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. | Visit link >> |
| IEC/ISO | 80369-7 | Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications | ISO 80369-7:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. | Visit link >> |
| IEC/ISO | 80369-20 | Small-bore connectors for liquids and gases in healthcare applications -- Part 20: Common test methods | ISO 80369-20:2015 specifies the test methods to evaluate the performance requirements for small-bore connectors specified in the ISO 80369- series. | Visit link >> |
| IEC/ISO | 80369-5:2016 | Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications | IEC 80369-5:2016 specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessoires. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff. | Visit link >> |
| ISO | 13485 | Medical devices -- Quality management systems -- Requirements for regulatory purposes | Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. | Visit link >> |
| ISO | 18562 | Biocompatibility Evaluation of Respiratory Gas Pathways in Healthcare Applications | Specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. | Visit link >> |
| ISO | 14644-1:2015 | Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration | ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones; and separative devices as defined in ISO 14644-7. The use of light scattering (discrete) airborne particle counters (LSAPC) is the basis for determination of the concentration of airborne particles, equal to and greater than the specified sizes, at designated sampling locations. | Visit link >> |
| ISO | 11135:2014 | Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices | ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications. | Visit link >> |
| ISO | 11137-1:2006 | Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. | Visit link >> |
| ISO | 15223-1:2016 | Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | ISO 15223-1:2016 identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document. | Visit link >> |
| ISO | 14971 | Medical devices -- Application of risk management to medical devices | ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device. | Visit link >> |
| ISO | 17664 | Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices | ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. | Visit link >> |
| ISO | 10993-1:2018 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process | The general principles governing the biological evaluation of medical devices within a risk management process; the identification of additional data sets necessary to analyse the biological safety of the medical device; the assessment of the biological safety of the medical device. | Visit link >> |
| ISO | 10993-5 | Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters. | Visit link >> |
| ISO | 10993-7 | Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals | specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, and methods for determining compliance so that devices may be released. Additional background, including guidance and a flowchart showing how the standard is applied are also included in informative annexes | Visit link >> |
| ISO | 10993-9 | Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products | Provides general principles for the systematic evaluation of the potential and observed biodegradation of medical devices and for the design and performance of biodegradation studies | Visit link >> |
| ISO | 10993-12 | Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials | Specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. | Visit link >> |
| ISO | 10993-13 | Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices | Provides general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use | Visit link >> |
| ISO | 10993-14 | Biological evaluation of medical devices -- Part 14: Identification and quantification of degradation products from ceramics | Specifies two methods of obtaining solutions of degradation products from ceramics (including glasses) for the purposes of quantification. It also gives guidance on the analysis of these solutions in order to identify the degradation products. | Visit link >> |
| ISO | 10993-15 | Biological evaluation of medical devices -- Part 15: Identification and quantification of degradation products from metals and alloys | Provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from finished metallic medical devices or corresponding material samples finished as ready for clinical use. It is applicable only to those degradation products generated by chemical alteration of the finished metallic device in an in vitro accelerated degradation test. | Visit link >> |
| ISO | 10993-17 | Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances | Specifies the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. | Visit link >> |
| ISO | 10993-18 | Biological evaluation of medical devices -- Part 18: Chemical characterization of materials | Describes a framework for the identification of a material and the identification and quantification of its chemical constituents | Visit link >> |
| ISO | 14949 | Implants for surgery -- Two-part addition-cure silicone elastomers | This International Standard specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants. | Visit link >> |
| ISO | 18562-1 | Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process | Specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. | Visit link >> |
| ISO | 18562-2 | Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter | specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,2 µm diameter to 10 µm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. | Visit link >> |
| ISO | 18562-3 | Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs) | specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of vocs that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests. | Visit link >> |
| ISO | 18562-4 | Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 4: Tests for leachables in condensate | specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. | Visit link >> |
| ISO | 16671 | Ophthalmic implants -- Irrigating solutions for ophthalmic surgery | defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer. | Visit link >> |
| ISO | 16672 | Ophthalmic implants -- Ocular endotamponades | Applies to ocular endotamponades (OE), a group of non-solid implants used in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina | Visit link >> |
| ISO | 15798 | Ophthalmic implants -- Ophthalmic viscosurgical devices | Is applicable to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the human eye. specifies requirements with regard to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information supplied by the manufacturer of these devices | Visit link >> |
| ISO | 11607-1 | Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems | Specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems | Visit link >> |
| ISO | 11607-2 | Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes | specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. | Visit link >> |
| ISO | 2233 | Packaging -- Complete, filled transport packages and unit loads -- Conditioning for testing | This International Standard specifies a method for the conditioning of complete, filled, transport packages and unit loads. | Visit link >> |
| ISO | 2248 | Packaging -- Complete, filled transport packages -- Vertical impact test by dropping | Raising of the test package above a rigid plane surface and releasing it to strike this surface (the "impact surface") after a free fall. The atmospheric conditions, the height of drop and the attitude of the package are predetermined. An annex gives the predetermined attitude of the test package. | Visit link >> |
| ISO | 8318 | Packaging -- Complete, filled transport packages and unit loads -- Sinusoidal vibration tests using a variable frequency | specifies two methods for carrying out a sinusoidal vibration test on a complete, filled transport package or unit load using a variable frequency. These tests may be used to assess the performance of a package or an unit load in terms of its strength or the protection that it offers to its contents when it is subjected to vertical vibration. Each may be performed either as a single test to investigate the effects of vertical vibration or as part of a sequence of tests designed to measure the ability of a package or unit load to withstand a distribution system that includes a vibration hazard. | Visit link >> |
| ISO | 11737-2 | Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. | Visit link >> |
| ISO | 17665-1 | Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices | specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. | Visit link >> |
| ISO | 11138-1 | Sterilization of health care products -- Biological indicators -- Part 1: General requirements | Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. | Visit link >> |
| ISO | 14937 | Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices | Specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. | Visit link >> |
| ISO | 11737-1 | Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products | Specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. | Visit link >> |
| ISO | 14698-2 | Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data | ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1. | Visit link >> |
| ISO | 14698-1 | Cleanrooms and associated controlled environments -- Biocontamination control -- Part 1: General principles and methods | ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. | Visit link >> |
| ISO | 14630 | Non-active surgical implants -- General requirements | ISO 14630:2012 specifies general requirements for non-active surgical implants. ISO 14630:2012 is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal tissue. | Visit link >> |
| ISO | 3826-1 | Plastics collapsible containers for human blood and blood components -- Part 1: Conventional containers | ISO 3826-1:2003 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers complete with collecting tube outlet port(s), integral needle and with optional transfer tube(s), for the collection, storage, processing, transport, separation and administration of blood and blood components. | Visit link >> |
| ISO | 3826-3 | Plastics collapsible containers for human blood and blood components -- Part 3: Blood bag systems with integrated features | ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems). The integrated features refer to:leucocyte filter; pre-donation sampling device; top and bottom bag; platelet storage bag; needle stick protection device. In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units. | Visit link >> |
| ISO | 8536-4 | Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity feed | ISO 8536-4:2010 specifies requirements for single use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. | Visit link >> |
| ISO | 8536-8 | Infusion equipment for medical use -- Part 8: Infusion sets for single use with pressure infusion apparatus | ISO 8536-8:2015 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar). | Visit link >> |
| ISO | 15883-1:2006 | Washer-disinfectors -- Part 1: General requirements, terms and definitions and tests | ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. | Visit link >> |
| ISO | 11979-5 | Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility | ISO 11979-5:2006 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test. | Visit link >> |
| ISO | 11979-2 | Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods | ISO 11979-2:2014 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor ?IOL' used throughout ISO 11979-2:2014 also includes phakic intraocular lenses (PIOL). | Visit link >> |
| ISO | 11979-3 | Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods | ISO 11979-3:2006 specifies requirements and test methods for certain mechanical properties of intraocular lenses | Visit link >> |
| ISO | 11979-4 | Ophthalmic implants -- Intraocular lenses -- Part 4: Labelling and information | ISO 11979-4:2008 specifies the labelling requirements for intraocular lenses (IOLs) and the information to be provided within or on the packaging. | Visit link >> |
| ISO | 11979-5 | Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility | ISO 11979-5:2006 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test. | Visit link >> |
| ISO | 11979-6 | Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability testing | ISO 11979-6:2014 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage. | Visit link >> |
| ISO | 14708-1 | Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer | ISO 14708-1:2014 is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources (for example by gas pressure or by springs). | Visit link >> |
| ISO | 11040-4 | Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling | Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling | Visit link >> |
| ISO | 9626 | Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods | ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device. | Visit link >> |
| ISO | 10555-1 | Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements | ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application. | Visit link >> |
| ISO | 10555-3 | Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters | ISO 10555-3:2013 specifies requirements for central venous catheters supplied in the sterile condition, and intended for single use. | Visit link >> |
| ISO | 7864 | Sterile hypodermic needles for single use -- Requirements and test methods | ISO 7864:2016 specifies requirements for sterile hypodermic needles for single use of designated metric sizes 0,18 mm to 1,2 mm.It does not apply to those devices that are covered by their own standard such as dental needles and pen needles. | Visit link >> |
| ISO | 11070 | Sterile single-use intravascular introducers, dilators and guidewires | ISO 11070:2014 specifies requirements for introducer needles, introducer catheters, sheath introducers, guidewires, and dilators supplied in the sterile condition, and intended for single use in conjunction with intravascular catheters. | Visit link >> |
| ISO | 5366-1 (Currently Withdrawn) | Anaesthetic and respiratory equipment -- Tracheostomy tubes -- Part 1: Tubes and connectors for use in adults | NA | Visit link >> |
| ISO/IEC | 17021-1:2015 | Conformity assessment -- Requirements for bodies providing audit and certification of management systems -- Part 1: Requirements | ISO/IEC 17021-1:2015 contains principles and requirements for the competence, consistency and impartiality of bodies providing audit and certification of all types of management systems. | Visit link >> |
| Ph. Eur. | 3.2.4 | Parenteral preparations are sterile preparations intended for administration by injection, infusion or implantation into the human or animal body. | Parenteral preparations are supplied in glass containers (3.2.1) or in other containers such as plastic containers (3.2.2, 3.2.2.1 and 3.2.9) and prefilled syringes. | Visit link >> |
| Ph. Eur. | 2.6.1 | Sterility Tests | The test is applied to substances, preparations or articleswhich, according to the Pharmacopoeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating micro-organism has been found in the sample examined in the conditions of the test. Guidancefor using the test for sterility is given at the end of this text. | Visit link >> |
| Ph. Eur. | 5.1.3 | TEST FOR EFFICACY OF ANTIMICROBIAL PRESERVATION | The test consists of challenging the preparation, wherever possible in its final container, with a prescribed inoculum of suitable micro-organisms, storing the inoculated preparation at a prescribed temperature, withdrawing samples from the container at specified intervals of time and counting the organisms in the samples so removed. | Visit link >> |
| Ph. Eur. | 2.6.12 | MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS: MICROBIAL ENUMERATION TESTS | The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality | Visit link >> |
| Ph. Eur. | 2.6.13 | Microbiological examination of non-sterile products- test for specified Microorganisms | The tests are designed primarily to detect bateria that belong to the family Enterobacteriaceae | Visit link >> |
| Ph. Eur. | 2.6.14 | BACTERIAL ENDOTOXINS | The test for bacterial endotoxins is used to detect or quantify endotoxins of gram-negative bacterial origin using amoebocyte lysate from horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). | Visit link >> |
| Ph. Eur. | 2.9.19 | PARTICULATE CONTAMINATION: SUB-VISIBLE PARTICLES | Particulate contamination of injections and infusions consists of extraneous, mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions. | Visit link >> |
| Ph. Eur. | 2.8.20 | The common regulations on the quality of medicinal products and starting materials |
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| UL | 2900 | Software Cybersecurity for Network-Connectable Products | This security evaluation standard applies to the testing of network connected components of healthcare systems. It applies to, but is not limited to, the following key components: Medical devices; Accessories to medical devices, Medical device data systems; In vitro diagnostic devices, Health information technology; and Wellness devices. | Visit link >> |
| UL | 416 | Refrigerated Medical Equipment | These requirements cover refrigerated medical equipment such as thermia and oxygen therapy devices for use in hospitals, nursing homes, medical care centers, medical and dental offices, and similar health care facilities in accordance with the National Electric Code, NFPA 70 | Visit link >> |
| UL | 1637 | Home Health Care Signaling Equipment | These requirements cover the individual units that comprise a home health care system intended for use in ordinary indoor residential locations. These requirements also cover a complete home health care system in which a signal initiating device (both routine monitoring and medical emergency signals) may be connected directly or indirectly to receiving equipment at a residence or to continuously monitored receiving equipment at a central supervising station. The system is arranged so that a predetermined change in the status of the signal initiating circuits or devices automatically causes transmission of a signal over a communication channel to receiving equipment at a residence, to a central supervising station, or to a private telephone number. | Visit link >> |
| UL | 1069 | Standard for Hospital Signaling and Nurse Call Equipment | These requirements cover the individual units employed to form a hospital nurse call system (NCS) intended to provide audible and visual communication between patients and hospital personnel. They also cover miscellaneous signaling equipment employed in hospitals. Some examples include bedside tables, annunciators, power supplies for nurse call systems, and gas monitoring units. The units covered by these requirements are intended to be installed in either general or critical care areas in accordance with the National Electrical Code, NFPA 70, and the Standard for Health Care Facilities, NFPA 99. | Visit link >> |
| UL | 2560 | Standard for Emergency Call Systems for Assisted Living and Independent Living Facilities | These requirements cover the individual unit employed to form assisted and independent living emergency call systems (ECS) intended to provide audible and visual signaling between residents and assisted and independent living facility staff. Some examples include call initiation stations, call notification stations, and power supplies | Visit link >> |
| UL | 2800-1 | Interoperable Medical Device Interface Safety | Defines the safety and related specifications of medical device interface(s) required when it is declared an interoperable medical device. The standard will address the available medical device interface characteristics needed to operate under safe interoperable conditions. The standard will focus on the safety and risks mitigation associated to the interoperability of the medical device interface within an ICE (Integrated Clinical Environment) and IS (Interoperable Scenario). | Visit link >> |
| UL | 1431 | Standard for Personal Hygiene and Health Care Appliances | These requirements cover household electric products having personal hygienics or health care applications, such as hydromassage units, contact lens disinfectors and cleaners, and toothbrushes, rated at 250 V or less, for use on premises wiring systems in accordance with the National Electrical Code. | Visit link >> |
| UL | 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements | Safety requirements for electrical equipment for measurement, control, and laboratory use specifies general safety requirements for the following types of electrical equipment and their accessories, wherever they are intended to be used.
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| USP | 87 | Biological Reactivity Tests, In Vitro (Cytotoxicity) | NA | Visit link >> |
| USP | 71 | Sterility Tests | The test is applied to substances, preparations, or articles which, according to the Pharmacopeia, are required to be sterile. However, a satisfactory result only indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test. | Visit link >> |
| USP | 51 | Preservative Challenge Test | The USP Chapter 51 Preservative Challenge Test is the most common method used to gauge preservative effectiveness. Much like a Preservative Challenge Screen, it is used to evaluate the effect of preservatives in cosmetics, personal care products, and drug products. | Visit link >> |
| USP | 61 | Microbiological examination of non-sterile products- Enumeration Tests | The USP 61 test is performed in routine to determine the "total aerobic microbial count" (TAMC) and "total yeasts and molds counts" (TYMC). | Visit link >> |
| USP | 788 | Particulate matter in injections | Particulate matter in injections and parenteral infusions consists of mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions. | Visit link >> |
| USP | 789 | PARTICULATE MATTER IN OPHTHALMIC SOLUTIONS | The tests described herein are physical tests performed for the purpose of enumerating extraneous particles within specific size ranges | Visit link >> |
| USP | 661 | Plastic Packaging Systems and Their Materials of Construction | provide standards for plastic materials and components used to package medical articles (pharmaceuticals, biologics, dietary supplements, and devices) | Visit link >> |
Please contact us with any questions in relation to this or other industry standards.
About AAMI
The AAMI standards program consists of over 100 technical committees and working groups that produce Standards, Recommended Practices, and Technical Information Reports for medical devices.
Standards and Recommended Practices represent a national consensus and many have been approved by the American National Standards Institute (ANSI) as American National Standards. AAMI also administers a number of international technical committees of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
About ANSI
The American National Standards Institute (ANSI) has served in its capacity as administrator and coordinator of the United States private sector voluntary standardization system for more than 100 years. Founded in 1918 by five engineering societies and three government agencies, the Institute remains a private, nonprofit membership organization supported by a diverse constituency of private and public sector organizations.
ANSI facilitates the development of American National Standards (ANS) by accrediting the procedures of standards developing organizations (SDOs). These groups work cooperatively to develop voluntary national consensus standards. Accreditation by ANSI signifies that the procedures used by the standards body in connection with the development of American National Standards meet the Institute’s essential requirements for openness, balance, consensus and due process.
As of January 2018, some 237 standards developers were accredited by ANSI; there were more than 11,500 American National Standards.
About ASTM
ASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.
ASTM International standards are the tools of customer satisfaction and competitiveness for companies across a wide range of markets. Through more than 140 technical standards-writing committees, we serve a broad range of industries: metals, construction, petroleum, consumer products and many more. When new industries — like nanotechnology, additive manufacturing and industrial biotechnology — look to advance the growth of cutting-edge technologies through standardization, many of them come to ASTM International.
About IEC
IEC provides a platform to companies, industries and governments for meeting, discussing and developing the International Standards they require.
All IEC International Standards are fully consensus-based and represent the needs of key stakeholders of every nation participating in IEC work. Every member country, no matter how large or small, has one vote and a say in what goes into an IEC International Standard.
About ISO
ISO is an independent, non-governmental international organization with a membership of 162 national standards bodies.
Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.
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