15/30329923 DC : 0
NA
Status of Standard is Unknown
BS EN ISO 22610 - SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES, FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - TEST METHOD TO DETERMINE THE RESISTANCE TO WET BACTERIAL PENETRATION
Hardcopy , PDF
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
5 Equipment, reagents and materials
6 Apparatus
7 Preparation of the Agar Plates
8 Bacterial inoculum
9 Procedure
10 Evaluation
11 Expression of the results
12 Report
Annex A (normative) - Apparatus for testing resistance
to wet bacterial penetration
Annex B (normative) - Nutrient media
Annex C (normative) - Equipment and laboratory
performance monitoring
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive (Add the reference
and title of the Directive)
BS EN ISO 22610.
| Committee |
CH/205/1
|
| DocumentType |
Draft
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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