ISO 28620:2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical devices Non-electrically driven portable infusion devices
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
16-01-2020
English, French
05-02-2010
ISO 28620:2010 specifies essential requirements and related test methods for non-electrically driven portable infusion devices. It applies to devices designed for continuous (fixed or adjustable) flow and/or for bolus application.
These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient.
These devices can be pre-filled by the manufacturer or filled before use by a health care professional or the intended patient.
| DevelopmentNote |
Supersedes ISO/DIS 28620. (02/2010)
|
| DocumentType |
Standard
|
| Pages |
11
|
| PublisherName |
International Organization for Standardization
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF ISO 28620 : 2010 | Identical |
| NEN ISO 28620 : 2010 | Identical |
| BS ISO 28620:2010 | Identical |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements |
| IEC 60601-2-24:2012 | Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
| ISO 554:1976 | Standard atmospheres for conditioning and/or testing — Specifications |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| 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 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN 13868:2002 | Catheters - Test methods for kinking of single lumen catheters and medical tubing |
| 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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