PREN ISO 17664 : DRAFT 2001

Name: PREN ISO 17664 : DRAFT 2001
Brand: CEN

Superseded

STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES

Superseded date

01-03-2004

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Information to be provided by the manufacturer
4 Presentation of the information
5 Validation of the reprocessing information
  provided
6 Risk analysis
Annex A (informative) Commonly utilized reprocessing
         methods
         A.1 General
         A.2 Matrix
Annex B (informative) An example of reprocessing
         instructions for reusable medical devices
         B.1 General
         B.2 Reprocessing instructions (reusable
             medical devices)
         Example template
Annex ZA (informative) Clauses of this European
          Standard addressing essential requirements
          or other provisions of EU Directives
Bibliography

Defines information to be provided by the manufacturer on the reprocessing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the user and requirements for validation of this information. It excludes textile devices used in patient draping systems or surgical clothing.

Committee	TC 204
DocumentType	Draft
PublisherName	Comite Europeen de Normalisation
Status	Superseded

Standards	Relationship
DIN EN ISO 17664:2016-06 (Draft)	Identical
01/561624 DC : DRAFT APR 2001	Identical

PREN 868-8 : DRAFT 2017	PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS
PREN ISO 15883-2 : DRAFT 2002	WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC
03/700194 DC : DRAFT FEB 2003	BS EN ISO 15883-2 - WASHER-DISINFECTORS - PART 2: REQUIREMENTS AND TESTS FOR WASHER-DISINFECTORS EMPLOYING THERMAL DISINFECTION FOR SURGICAL INSTRUMENTS, ANAESTHETIC EQUIPMENT, HOLLOWWARE, UTENSILS, GLASSWARE, ETC.
17/30360915 DC : 0	BS EN 868-8 - PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS