Hälso- och sjukvård

This International Standard specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.

The relationship between clauses in this international standard and ISO/IEC 17025:2017 are summarized in Annex A.

Examinations of properties with results reported on a nominal or ordinal scale are not included.

This International Standard is not applicable to medical laboratories.

NOTE 1 It is the laboratory’s responsibility to comply with the relevant legal health and safety requirements.

NOTE 2 Requirements for medical laboratories are specified in ISO 15189.

This document specifies test methods and procedures for assessing the accuracy and external reliability of a three-dimensional numerical description of intra-oral surfaces acquired directly from a patient with a hand-held scanning device. The test methods are not applicable to ultrasonic, radiographic or magnetic resonance imaging methods.

Note: ISO 12836:2015 specifies the test methods for the assessment of accuracy of digitizing devices that use a fixed or a mechanically guided scanning device.

This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.

This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see Note 1).

This document is not applicable to material of human origin.

This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see Note 2 and Note 3).

This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.

The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see Note 4).

This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see Note 5).

This document does not cover the level of residual sterilizing agent within medical devices (see Note 6).

This document does not describe a quality management system for the control of all stages of manufacture (see Note 7).

NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1, is important.

NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.

NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.

NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a defined sterilization process.

NOTE 5 Such testing is a crucial part of the design and development of a medical device.

NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.

NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993- series.

This document considers both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to:

a) evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available;

NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and thus need to undergo biological evaluation as described in other parts of ISO 10993.

b) leachable components which are not degradation products;

c) medical devices or components that do not contact the patient's body directly or indirectly.

This document provides guidance on general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use.

This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro accelerated degradation test. Because of the accelerated nature of these tests, the test results may not reflect the implant or material behavior in the body. The described chemical methodologies are a means to generate degradation products for further assessments.

This document considers both materials designed to degrade in the body as well as materials that are not intended to degrade.

This document is not applicable to degradation products induced by applied mechanical stress.

Mechanically induced degradation, such as wear, can be covered in the appropriate product-specific standard. Where product-group standards provide applicable product-specific methodologies for the identification and quantification of degradation products, those standards should be considered.

Because of the wide range of metallic materials used in medical devices, no specific analytical techniques are identified for quantifying the degradation products. The identification of trace elements (< 10 –6 w/w) contained in the specific metal or alloy is not addressed in this part of ISO 10993, nor are specific requirements for acceptable levels of degradation products provided in this part of ISO 10993.

This document does not address the biological activity of the degradation products; see instead the applicable clauses of ISO 10993-1 and ISO 10993-17.

This document describes a procedure for the determination of ochratoxin A (OTA) in chilli, paprika, black and white pepper, nutmeg, spice mix, liquorice (root and extracts), cocoa and cocoa products by high performance liquid chromatography (HPLC) with immunoaffinity column clean-up and fluorescence detection.

This method has been validated in interlaboratory studies via the analysis of both naturally contaminated and spiked samples ranging from 1,0 μg/kg to 84,9 μg/kg for spices (paprika and chili [5], black and white pepper, nutmeg and spice mix [6]), ranging from 7,7 μg/kg to 96,8 μg/kg for liquorice [7] and ranging from 2,1 μg/kg to 26,3 μg/kg for cocoa and cocoa products [6].

For further information on the validation see Clause 9 and Annex B.

This document specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.

The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.

This document was designed for Bradyarrhythmia PULSE generators used with endocardial or epicardial LEADS. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of MANUFACTURERS incorporating these technologies.

This document is also applicable to some non-implantable parts and ACCESSORIES of the devices (see NOTE 1).

The electrical characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.

Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by ISO 14708-6.

NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more ACCESSORIES. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and ACCESSORIES if they could affect the safety or performance of the implantable device.

NOTE 2 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

This document specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CRT-DS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.

The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.

This document was designed for tachyarrhythmia PULSE generators used with either endocardial or epicardial LEADs. At the time of this edition, the authors recognized the emergence of technologies that do not use ENDOCARDIAL or EPICARDIAL LEADS for which adaptations of this part will be required. Such adaptations are left to the discretion of MANUFACTURERS incorporating these technologies.

This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).

The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either theappropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.

Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.

NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE might in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.

NOTE 3 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this document.

This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included:

a) processing, distribution and retailing of:

1) food of animal origin:  
— milk and milk products;  
— meat and meat products;  
— fish, seafood, and related products;  
— eggs and egg products;  
— animal feeds;  
— etc.

2) food of vegetable origin:
— beverages;
— fruits, vegetables and derivatives (including sugar, distillery ...);
— flour, milling and baking;
— animal feeds;
— etc.

b) institutional and domestic areas:
— catering establishments;
— public areas;
— public transports;
— schools;
— nurseries;
— shops;
— sports rooms;
— waste containers (bins ...);
— hotels;
— dwellings;
— clinically non-sensitive areas of hospitals;
— offices;
— etc.

c) other industrial areas:
— packaging material;
— biotechnology (yeast, proteins, enzymes, ...);
— pharmaceutical;
— cosmetics and toiletries;
— textiles;
— space industry, computer industry;
— etc.

EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2 This method corresponds to a phase 2 step 1 test.

This document applies to the safety of APTI, which make claims to redistribute the load of the full body, remain in situ during periods of lying, and to prevent and/or treat pressure injuries.

This document covers a range of different lying support surfaces intended to be used in combination with the appropriate support platform or as a whole integrated system.

This document also covers assistive products primarily intended for tissue integrity for changing a lying position and assistive products for maintaining a lying position.

This document does not apply to lying support surfaces used in combination with incubators.

This document will address the combination of a full body support surface and an adjustable mattress support platform. Safety and performance test methods to ensure protection against injuries to the user are the aspects that this document will cover.

This document specifies requirements and test methods for assistive products within the following divisions of ISO 9999:2016:

04 33 06 Assistive products for tissue integrity (APTI) when lying down:

— Mattresses and mattress overlays for pressure injury prevention;

— Mattress coverings for pressure injury prevention mattresses.

12 31 03 Assistive products for sliding and turning:

Devices for changing position or direction of a person using sliding or turning techniques. Only included are the following products intended to be used in a lying position and remain in situ as part of the lying support surface:

— Sliding products that glide one way and lock the other way;

— Sheets and underlays in flexible materials with low friction;

— Fabric sold by the metre, cut as required for repositioning use;

— Powered turning product;

This excludes sliding boards.

09 07 06 Positioning pillows, positioning cushions and positioning systems e.g:

— Leg positioners;

— Arm positioners;

— Multipurpose body positioners.

18 12 15 Bedding:

— Draw sheets

NOTE Through the use of this document, clinicians and manufacturers should consider the impact of other items (including additional APTI) used in conjunction with an APTI on tissue integrity and safety.

This European Standard specifies a test method (phase 2/step 2) and the minimum requirements for bactericidal and/or fungicidal or yeasticidal activity of chemical disinfectants that form a homogeneous physically stable preparation in hard water or – in the case of ready-to-use products – with water in food, industrial, domestic and institutional areas, excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues. The scope of this European Standard applies at least to the following: a) Processing, distribution and retailing of: 1) Food of animal origin: i) milk and milk products; ii) meat and meat products; iii) fish, seafood and products; iv) eggs and egg products; v) animal feeds; vi) etc. 2) Food of vegetable origin: i) beverages; ii) fruits, vegetables and derivatives (including sugar distillery); iii) flour, milling and backing; iv) animal feeds; v) etc. b) Institutional and domestic areas: 1) catering establishments; 2) public areas; 3) public transports; 4) schools; 5) nurseries; 6) shops; 7) sports rooms; 8) waste container (bins); 9) hotels; 10) dwellings; 11) clinically non sensitive areas of hospitals; 12) offices; 13) etc. c) Other industrial areas: 1) packaging material; 2) biotechnology (yeast, proteins, enzymes...); 3) pharmaceutical; 4) cosmetics and toiletries; 5) textiles; 6) space industry, computer industry; 7) etc. Using this European Standard, it is possible to determine the bactericidal or fungicidal or yeasticidal activity of the undiluted product. As three concentrations are tested, in the active to non active range, dilution of the product is required and, therefore, the product forms a homogeneous stable preparation in hard water. EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances on bacteria and/or fungi in the conditions in which they are used. NOTE 2 This method cannot be used to evaluate the activity of products against mycobacteria.

1.1 This document 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. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

1.2 This document is not applicable to:

a) sterility testing for routine release of product that has been subjected to a sterilization process,

b) performing a test for sterility (see 3.12), and

NOTE 1 The performance of a) or b) is not a requirement of ISO 11135, ISO 11137-1, ISO 14160, ISO 14937, ISO 17665-1 or ISO 20857.

c) culturing of biological indicators or inoculated products.

NOTE 2 Guidance on culturing biological indicators is included in ISO 11138-7[5].