ISO 28620:2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical devices Non-electrically driven portable infusion devices
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
01-01-2020
English, French
02-05-2010
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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 |
Withdrawn
|
| 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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