BS EN ISO 20857:2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization/depyrogenation
12 Maintaining process effectiveness
Annex A (informative) - Guidance on the application of
        this International Standard
Annex B (informative) - Process definition based on
        inactivation of the microbial population in its
        natural state (bioburden-based approach)
Annex C (informative) - Process definition based on the
        inactivation of reference microorganisms and
        knowledge of bioburden (combined bioburden/biological
        indicator approach)
Annex D (informative) - Conservative process definition
        based on inactivation of reference microorganisms
        (overkill method)
Annex E (informative) - Process development
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable Medical
         Devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZC (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 98/79/EC on in vitro diagnostic medical
         devices

Defines requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.

1.1 Inclusions

1.1.1

This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.

NOTE Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that might be applicable to other health care products.

1.1.2

Although this International Standard primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.

NOTE Dry heat is often used for the depyrogenation of equipment, components and health care products and its effectiveness has been demonstrated. The process parameters for sterilization and/or depyrogenation are time and temperature. Because the conditions for depyrogenation are typically more severe than those required for sterilization, a process that has been validated for product depyrogenation will result in product sterility without additional validation.

1.2 Exclusions

1.2.1

This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.

NOTE See also ISO22442-1, ISO22442-2 and ISO22442-3.

1.2.2

This International Standard does not apply to processes that use infrared or microwaves as the heating technique.

1.2.3

This International Standard does not detail a specified requirement for designating a medical device as \'sterile.\'

NOTE Attention is drawn to national or regional requirements for designating medical devices as “sterile.” See, for example, EN556-1 or ANSI/AAMI ST67.

1.2.4

This International Standard does not specify a quality management system for the control of all stages of production of medical devices.

NOTE It is not a requirement of this International Standard to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause4). Attention is drawn to the standards for quality management systems (see ISO13485) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.

1.2.5

This International Standard does not specify requirements for occupational safety associated with the design and operation of dry heat sterilization and/or depyrogenation facilities.

NOTE Requirements for operational safety are specified in IEC61010-2-040. Additionally, safety regulations exist in some countries.