PREN ISO 17664 : DRAFT 2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
STERILIZATION OF MEDICAL DEVICES - INFORMATION TO BE PROVIDED BY THE MANUFACTURER FOR THE REPROCESSING OF RESTERILIZABLE DEVICES
01-03-2004
12-01-2013
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Superseded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 |
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