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

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

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