04/30048301 DC : DRAFT MAY 2004

Superseded

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BS EN ISO 11137-1 - STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES

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Superseded date: 31-08-2006

Language(s):

Published date: 23-11-2012

Publisher: British Standards Institution

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Introduction
1 Scope
   1.1 Inclusions
   1.2 Exclusions
2 Normative references
3 Terms and definitions
4 Quality management system elements
   4.1 Documentation
   4.2 Management responsibility
   4.3 Product realization
   4.4 Measurement, analysis and improvement - Control of
        nonconforming product
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
6 Process and equipment characterization
   6.1 Process
   6.2 Equipment
7 Product definition
8 Process definition
   8.1 Establishing the maximum acceptable dose
   8.2 Establishing the sterilization dose
   8.3 Specifying the sterilization dose and the maximum
        acceptable dose
   8.4 Transference of maximum acceptable, verification or
        sterilization dose between radiation sources
9 Validation
   9.1 Installation qualification
   9.2 Operational qualification
   9.3 Performance qualification
   9.4 Review and approval of validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
   12.1 Demonstration of continued effectiveness
   12.2 Recalibration
   12.3 Maintenance of equipment
   12.4 Requalification of equipment
   12.5 Assessment of change
Annex A (informative) Guidance
      A.1 Scope
      A.2 Normative references
      A.3 Terms and definitions
      A.4 Quality management system elements
      A.5 Sterilizing agent characterization
      A.6 Process and equipment characterization
      A.7 Product definition
      A.8 Process definition
      A.9 Validation
      A.10 Routine monitoring and control
      A.11 Product release from sterilization
      A.12 Maintaining process effectiveness
Bibliography
Annex ZA (normative) Normative references to international
                       publications with their relevant European
                       publications
Annex ZB (informative) Relationship between this European
                       Standard and the Essential Requirements of
                       EU Directives 90/358/EEC of 20 June 1990
                       concerning active implantable medical
                       devices, 93/42/EEC of 14 June 1993
                       concerning medical devices and 98/78/EC of
                       7 December 1988 concerning in vitro
                       diagnostic medical devices

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BS EN ISO 1137-1

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Comment Closes On
Committee	CH/198
Document Type	Draft
ISBN
Pages
Published
Publisher	British Standards Institution
Status	Superseded
Superseded By	BS EN ISO 11137-1:2015

Standards Referencing This Book - (Show below) - (Hide below)

EN 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 11737-2:2009)
EN 12442-3 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
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
AAMI TIR17 : 2008	COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
ISO 11137-3:2017	Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
ISO 14001:2015	Environmental management systems — Requirements with guidance for use
IEC 61010-2-041:1995	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-041: Particular requirements for autoclaves using steam for the treatment of medical materials, and for laboratory processes
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9001:2015	Quality management systems — Requirements
ISO 11607:2003	Packaging for terminally sterilized medical devices
EN 12442-1 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
ISO 14040:2006	Environmental management Life cycle assessment Principles and framework
ISO 10012-1:1992	Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
EN 12442-2 : 2000	ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING

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