BS ISO 19611:2017
Current
The latest, up-to-date edition.
Traditional Chinese medicine. Air extraction cupping device
Hardcopy , PDF
English
28-06-2017
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Configuration
5 Requirements
6 Package
7 Labelling
Annex A (normative) - Test methods for a cupping device
Bibliography
Gives requirements for an air extraction cupping device which operates using negative pressure.
| Committee |
CH/100/1
|
| DevelopmentNote |
Supersedes 16/30302520 DC. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
20
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document specifies requirements for an air extraction cupping device which operates using negative pressure. This document includes requirements for the material, pressure, sterilization or disinfection, and packaging of the cupping device, as well as appropriate test methods.
The document is applicable to single-use type and multiple-use type devices.
This document does not apply to the suction pump used to create the negative pressure.
| Standards | Relationship |
| ISO 19611:2017 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 2533:1975 | Standard Atmosphere |
| ISO/IEC Guide 63:2012 | Guide to the development and inclusion of safety aspects in International Standards for medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of 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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