BS EN ISO 25424 - STERILIZATION OF HEALTH CARE PRODUCTS - LOW TEMPERATURE STEAM AND FORMALDEHYDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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
12 Maintaining process effectiveness
Annex A (normative) - Process definition based on
        inactivation of reference microorganisms And
        knowledge of bioburden on product items to
        be sterilized
Annex B (normative) - Process definition based on
        inactivation of reference microorganisms
Annex C (informative) - Guidance on application of this
        International Standard
Annex D (informative) - Environmental aspects regarding
        development, validation and routine control of Low
        Temperature Steam and Formaldehyde processes
Annex ZA (informative) - Relationship between this
         European Standard and the Essential Requirements
         of EU Directive 90/385/EEC on active implantable
         medical devices
Bibliography

BS EN ISO 25424.

Committee	CH/198
DocumentType	Draft
Pages	52
PublisherName	British Standards Institution
Status	NA

IEC 61010-2-040:2015	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
ISO 11737-2:2009	Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-1:2006	Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 14937:2009	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
EN 867-5:2001	Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
EN 14180:2014	Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
ISO/TS 11139:2006	Sterilization of health care products Vocabulary
AAMI RD47 : 2008	REPROCESSING OF HEMODIALYZERS
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 10012:2003	Measurement management systems — Requirements for measurement processes and measuring equipment
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 11138-1:2017	Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO Guide 64:2008	Guide for addressing environmental issues in product standards
ISO 14161:2009	Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
ISO 11138-5:2017	Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
ISO 17664:2017	Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
1997/23/EC : 1997	DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT