BS EN ISO 7886-2:1997
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Sterile hypodermic syringes for single use Syringes for use with power-driven syringe pumps
Hardcopy , PDF
20-05-2020
English
15-09-1996
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1 Scope
2 Normative references
3 Definitions
4 Nomenclature
5 Cleanliness
6 Limits for acidity or alkalinity
7 Limits for extractable metals
8 Lubricant
9 Tolerance on graduated capacity
10 Graduated scale
11 Syringe design
12 Piston/plunger assembly
13 Nozzle
14 Performance
15 Packaging
16 Labelling
Annexes
A Determination of flow characteristics
B Determination of forces required to move the piston
C Rationale for flowrate characteristics
E Bibliography
Defines requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and over, made from plastics materials to be used with power-driven syringe pumps. Not applicable to syringes to be used with insulin, single use glass syringes, those prefilled with injection by the manufacturer and those supplied as a kit for filling by a pharmacist. Does not deal with compatibility with injection fluids.
| Committee |
CH/84
|
| DevelopmentNote |
Renumbers and supersedes BS ISO 7886-2 (07/2004) 1997 Version incorporates amendment 9835 to BS ISO 7886-2 Supersedes 94/508351 DC (06/2005) Reviewed and confirmed by BSI, November 2007. (10/2007)
|
| DocumentType |
Standard
|
| Pages |
24
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 7886-2 : 1998 | Identical |
| EN ISO 7886-2:1997 | Identical |
| NBN EN ISO 7886-2 : 1997 | Identical |
| NS EN ISO 7886-2 : 1ED 1998 | Identical |
| UNI EN ISO 7886-2 : 1998 | Identical |
| ISO 7886-2:1996 | Identical |
| UNE-EN ISO 7886-2:1998 | Identical |
| I.S. EN ISO 7886-2:1998 | Identical |
| SN EN ISO 7886-2 : 1998 | Identical |
| NEN EN ISO 7886-2 : 1997 | Identical |
| NF EN ISO 7886-2 : 1997 | Identical |
| DIN EN ISO 7886-2:1997-11 | Identical |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 595-2:1987 | Reusable all-glass or metal-and-glass syringes for medical use Part 2: Design, performance requirements and tests |
| EN ISO 7864:2016 | Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016) |
| ISO 7886-1:2017 | Sterile hypodermic syringes for single use — Part 1: Syringes for manual use |
| ISO 595-1:1986 | Reusable all-glass or metal-and-glass syringes for medical use Part 1: Dimensions |
| ISO 8601:2004 | Data elements and interchange formats Information interchange Representation of dates and times |
| ISO 7864:2016 | Sterile hypodermic needles for single use — Requirements and test methods |
| ISO 3696:1987 | Water for analytical laboratory use — Specification and test methods |
| 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 |
| EN ISO 3696:1995 | Water for analytical laboratory use - Specification and test methods (ISO 3696:1987) |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| EN 28601 : 1992 | DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
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