BS EN ISO 15883-7:2016
$189.07
Washer-disinfectors – Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive, non-critical thermolabile medical devices and healthcare equipment
| Published By | Publication Date | Number of Pages |
| BSI | 2016 | 50 |
This part of ISO 15883 specifies the particular requirements for washer-disinfectors (WD) intended to be used for the cleaning and chemical disinfection, in a single operating cycle, of reusable items such as the following:
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bedframes;
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bedside tables;
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transport carts;
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containers;
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surgical tables;
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sterilization containers;
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surgical clogs;
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wheelchairs, aids for the disabled.
This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be necessary in order to achieve the required performance.
Devices identified within the scopes of ISO 15883-2, ISO 15883-3, ISO I5883-4, and ISO 15883-6 do not fall within the scope of this part of ISO 15883.
In addition, the methods are specified, as well as instrumentation and instructions required for type testing, works testing, validation (installation, operation, and performance qualification on first installation), routine control, and monitoring, as well as requalifications required to be carried out periodically and after essential repairs.
NOTE WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection of other thermolabile and reusable devices as recommended by the device manufacturer.
The performance requirements specified in this part of ISO 15883 may not ensure the inactivation or removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 4 | European foreword Table — Correlation between normative references and dated EN and ISO standards |
| 6 | Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered Table ZA.1 — Correspondence between this European standard and Annex I of Directive 93/42/EEC [OJ L 169] |
| 9 | Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to Article 3 of amended Directive 93/42/EEC) |
| 15 | Foreword |
| 16 | Introduction |
| 17 | 1 Scope 2 Normative references |
| 18 | 3 Terms and definitions 4 Performance requirements 4.1 General |
| 19 | 4.2 Cleaning 4.3 Disinfection |
| 21 | 4.4 Final rinsing 4.5 Self-disinfection |
| 22 | 4.6 Drying 4.7 Water treatment equipment 4.7.1 General 4.7.2 Disinfection of water treatment equipment |
| 23 | 4.7.3 Maintenance of piping 5 Mechanical requirements 5.1 Materials — Design, manufacture, and assembly 5.2 Process verification 6 Testing for conformity 6.1 General |
| 24 | 6.2 Test load 6.2.1 Loading with standard goods 6.2.2 Loading with special goods 6.3 Water used for rinsing following disinfection 6.4 Load dryness 6.4.1 General 6.4.2 Procedure 6.4.3 Results 6.5 Thermometric tests 6.5.1 General 6.5.2 Load temperature test |
| 25 | 6.6 Chemical dosing tests 6.6.1 General 6.6.2 Reused process chemicals 6.7 Tests of cleaning efficacy 6.7.1 General 6.7.2 Materials |
| 26 | 6.7.3 Procedure 6.7.4 Results 6.8 Test of disinfection efficacy 6.8.1 General 6.8.2 Preliminary tests on chemical disinfectants |
| 27 | 6.8.3 Self-disinfection tests |
| 28 | 6.8.4 Chemical disinfection of the load 7 Documentation 8 Information to be provided by the manufacturer |
| 29 | 9 Marking, labelling, and packaging 10 Information to be requested from the purchaser by the manufacturer |
| 30 | Annex A (normative) Summary of test programmes |
| 32 | Annex B (normative) Methods for microbiological evaluation of disinfection of liquid transport system |
| 37 | Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water |
| 38 | Annex D (normative) Preparation and evaluation of indicators for microbiological testing of the efficacy of chemical disinfection of the load |
| 42 | Annex E (informative) Examples of test locations for the tests with biological indicators |
| 46 | Bibliography |
