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AAMI ST63 : 2002

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN INDUSTRIAL STERILIZATION PROCESS FOR MEDICAL DEVICES - DRY HEAT
Available format(s)

Hardcopy , PDF

Superseded date

08-12-2010

Language(s)

English

Published date

01-01-2002

Glossary of equivalent standards
Committee representation
Acknowledgment
Foreword
1 Scope
2 Normative references
3 Definitions
4 Quality systems
   4.1 Assignment of personnel responsibilities
   4.2 Documentation and records
   4.3 Design control
   4.4 Calibration
5 Sterilizing agent characterization
   5.1 Sterilizing agent
   5.2 Microbicidal effectiveness
   5.3 Material effects
   5.4 Safety and environment
6 Process and equipment characteristics
   6.1 General
   6.2 Process monitoring
        6.2.1 Process parameters
        6.2.2 Tolerance of the parameters
        6.2.3 Process monitoring locations
   6.3 Documentation of equipment
        6.3.1 Identification
        6.3.2 Safety
        6.3.3 Manuals and instructions
        6.3.4 Additional information
   6.4 Sterilization system performance, utilities,
        components, accessories, and controls
        6.4.1 Performance
        6.4.2 Utilities
        6.4.3 Components
        6.4.4 Accessories
        6.4.5 Control and recording systems
        6.4.6 Control programs
   6.5 Performance of instruments
        6.5.1 Instrument accuracy
        6.5.2 Calibration standards
        6.5.3 Calibration program
   6.6 Maintenance
7 Product definition
   7.1 Introduction
   7.2 Product considerations
   7.3 Packaging considerations
   7.4 Bioburden
8 Process definition
   8.1 Introduction
   8.2 Selection of the sterilization process
   8.3 Sterilization process development
        8.3.1 Process variables
        8.3.2 Sterility assurance level
        8.3.3 Cycle development
   8.4 Process challenge devices
   8.5 Sterility testing
   8.6 Biocompatibility
   8.7 Depyrogenation
9 Sterilization process validation
   9.1 General
   9.2 Installation qualification
   9.3 Operational qualification
   9.4 Performance qualification
        9.4.1 Performance qualification-Physical
        9.4.2 Performance qualification-Microbiological
   9.5 Parametric release
   9.6 Other sterilization systems
   9.7 Validation report
10 Routine monitoring and control
   10.1 Process control systems
   10.2 Process recording systems
   10.3 Microbiological testing
11 Product release
12 Maintaining process effectiveness
   12.1 Maintenance
   12.2 Calibration
   12.3 Requalification
   12.4 Change control
Annexes
A - Guidance on application of this standard
B - Bibliography

Describes requirements for the development, validation, and routine control of an industrial dry heat sterilization process for medical devices.

Committee
WG 42
DocumentType
Standard
Pages
54
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Superseded
SupersededBy

CAN/CSA-ISO/TS 16775:17 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)
S.R. CEN ISO/TS 16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2 (ISO/TS 16775:2014)
CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2014)
PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
AAMI ST67 : 2011 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
AAMI ST67 : 2011 : R2017 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS AND GUIDANCE FOR SELECTING A STERILITY ASSURANCE LEVEL (SAL) FOR PRODUCTS LABELED 'STERILE'
ANSI/AAMI/ISO TIR16775:2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
UNI CEN ISO/TS 16775 : 2014 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - GUIDANCE ON THE APPLICATION OF ISO 11607-1 AND ISO 11607-2

ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
AAMI ST59 : 1ED 99 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL
AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
ISO 9004:2009 Managing for the sustained success of an organization A quality management approach
ISO 9001:2015 Quality management systems — Requirements
IEC 61010-2-043:1997 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-043: Particular requirements for dry heat sterilizers using either hot air or hot inert gas for the treatment of medical materials, and for laboratory processes
AAMI ST60 : 1ED 96 STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 1: GENERAL REQUIREMENTS
AAMI ISO 13488 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9002
AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
ISO 10012-1:1992 Quality assurance requirements for measuring equipment Part 1: Metrological confirmation system for measuring equipment
AAMI ISO 11607 : 2ED 2000 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

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