ISO 7886-1-2017 Sterile hypodermic syringes for single use - Part 1 Syringes for manual use《一次性使用无菌皮下注射器 第1部分 手推注射器》.pdf

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1、 ISO 2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual use Seringues hypodermiques striles, non rutilisables Partie 1: Seringues pour utilisation manuelle INTERNATIONAL STANDARD ISO 7886-1 Second edition 2017-05 Reference number ISO 7886-1:2017(E) ISO 7886-1:2017(E)ii ISO 2

2、017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on th

3、e internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749

4、 09 47 copyrightiso.org www.iso.org ISO 7886-1:2017(E)Foreword v Introduction vi 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Nomenclature 3 5 General requirements . 5 6 Extraneous matter 5 6.1 General . 5 6.2 Limits for acidity or alkalinity . 5 6.3 Limits for extractable met

5、als 5 7 Lubricant 6 8 Tolerance on graduated capacity 6 9 Graduated scale . 7 9.1 Scale 7 9.2 Numbering of scales . 8 9.3 Overall length of scale to nominal capacity line . 8 9.4 Position of scale 9 10 Barrel 9 10.1 Dimensions . 9 10.2 Barrel flanges . 9 11 Plunger stopper/plunger assembly 9 11.1 De

6、sign . 9 12 Nozzle 10 12.1 Conical fitting 10 12.2 Position of nozzle on end of barrel .10 12.3 Nozzle lumen .10 13 Performance .10 13.1 Dead space .10 13.2 Freedom from air and liquid leakage past plunger stopper .10 13.3 Force to operate the piston10 13.4 Fit of plunger stopper/plunger in barrel 1

7、0 14 Packaging 11 14.1 Unit packaging and self-contained syringe units .11 14.1.1 Unit packaging 11 14.1.2 Self-contained syringe units .11 14.2 Multiple unit pack11 14.3 User packaging .11 15 Information supplied by the manufacturer 12 15.1 General 12 15.2 Syringes 12 15.2.1 General.12 15.2.2 Addit

8、ional marking for self-contained syringe units.12 15.3 Unit packaging 12 15.4 Multiple unit packs .13 15.4.1 General.13 15.4.2 Multiple unit packs with self-contained syringes.13 15.5 User packaging .13 ISO 2017 All rights reserved iii Contents Page ISO 7886-1:2017(E)15.6 Storage container .14 15.7

9、Transport wrapping 14 Annex A (normative) Method for preparation of extracts 15 Annex B (normative) Test method for air leakage past syringe plunger stopper during aspiration, and for separation of plunger stopper and plunger 16 Annex C (normative) Method for determination of dead space 18 Annex D (

10、normative) Test method for liquid leakage at syringe plunger stopper under compression .19 Annex E (informative) Test method for the determination of forces required to operate the piston .21 Annex F (informative) Test method for the quantity of silicone .25 Bibliography .28 iv ISO 2017 All rights r

11、eserved ISO 7886-1:2017(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested

12、 in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Comm

13、ission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO documents

14、 should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsibl

15、e for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www .iso .org/ patents). Any trade name used in this document is information given f

16、or the convenience of users and does not constitute an endorsement. For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principle

17、s in the Technical Barriers to Trade (TBT) see the following URL: w w w . i s o .org/ iso/ foreword .html. This document was prepared by Technical committee ISO/TC 84, Devices for administration of medicinal products and catheters. This second edition cancels and replaces the first edition (ISO 7886

18、-1:1993), which has been technically revised. It also incorporates the Technical corrigendum ISO 7886-1:1993/Cor.1:1995. The main changes to the previous edition are the following: a) clarified the Scope, e.g. excluding single-use syringes made of glass; b) added new Normative references; c) added n

19、ew terms and definitions; d) clarified the drawing to illustrate the component of the syringe; e) included general requirements; f) revised test methods for syringes; g) revised the labelling requirement; h) clarified the type of lubricant for the different types of syringes; i) replaced Annex E (in

20、formative): Examples of test methods for incompatibility between syringes and injection fluids with Annex E (informative): Test method for the determination of forces required to operate the piston; j) added Annex F (informative): Test method for the quantity of silicone; k) informative annex on mat

21、erials has been deleted. A list of all parts in the ISO 7886 series can be found on the ISO website. ISO 2017 All rights reserved v ISO 7886-1:2017(E) Introduction The ISO 7886 series covers hypodermic syringes primarily intended for human use and provides performance and testing requirements. It pe

22、rmits broader variation in design so as not to limit innovation and methods of packaging. Its appearance and layout are consistent with other related standards which are designed to be more performance-based compared to design prescriptive. General requirements as design guidelines for manufacturers

23、 are introduced in this document. Several limits for requirements which are historic based but confirmed in practice for many years have been kept. Materials to be used for the construction and lubrication of sterile syringes for single use are not specified as their selection will depend to some ex

24、tent upon the design, process of manufacture and sterilization method employed by individual manufacturers. The materials of the syringe should be compatible with injection fluids. If this is not the case, the attention of the user should be drawn to the exception by labelling on unit packaging. It

25、is not practicable to specify a universally acceptable test method for incompatibility, as the only conclusive test is that an individual specific injection fluid is compatible with a specific syringe. Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be

26、tested by the manufacturer of the injectable preparation for any possible incompatibility with the materials frequently used in syringe construction. If an incompatibility is identified, the injection fluid should be suitably labelled. The impossibility of testing any one injection fluid with all av

27、ailable syringes is recognized and it is strongly recommended that regulatory authorities and relevant trade associations should recognize the problem and take appropriate measures to assist manufacturers of injectable preparations. Syringes should be manufactured and sterilized in accordance with r

28、ecognized national or international codes of good manufacturing practice for medical devices. The sampling plans for inspection selected for the ISO 7886 series are intended to verify the design at a high confidence level. The sampling plans for inspection do not replace the more general manufacturi

29、ng quality systems requirements that appear in standards on quality systems, for example the ISO 9000 series and ISO 13485. Manufacturers are expected to follow a risk-based approach and employ usability engineering during the design, development and manufacture of syringes. Guidance on transition p

30、eriods for implementing the requirements of ISO 7886 (all parts) is given in ISO/TR 19244.vi ISO 2017 All rights reserved Sterile hypodermic syringes for single use Part 1: Syringes for manual use 1 Scope This document specifies requirements and test methods for verifying the design of empty sterile

31、 single- use hypodermic syringes, with or without needle, made of plastic or other materials and intended for the aspiration and injection of fluids after filling by the end-users. This document does not provide requirements for lot release. The syringes are primarily for use in humans. Sterile syri

32、nges specified in this document are intended for use immediately after filling and are not intended to contain the medicament for extended periods of time. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes for use with power-driven syringe pumps, s

33、yringes pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit for filling by a pharmacist). Hypodermic syringes without a needle specified in this document are intended for use with hypodermic needles specified in ISO 7864. 2 Normative references The followi

34、ng documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1522

35、3-1:2016, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements ISO 23908, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and

36、 needles used for blood sampling ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications 3 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. ISO and IEC ma

37、intain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform: available at h t t p :/ www .iso .org/ obp 3.1 nominal capacity capacity of the syringe as designated by the manufact

38、urer EXAMPLE 1 ml, 5 ml, 50 ml INTERNATIONAL ST ANDARD ISO 7886-1:2017(E) ISO 2017 All rights reserved 1 ISO 7886-1:2017(E) 3.2 graduated capacity volume of water, at 18 C to 28 C, expelled from the syringe when the fiducial line on the piston traverses a given scale interval or intervals 3.3 total

39、graduated capacity capacity of the syringe at the graduation line furthest from the zero graduation line 3.4 maximum usable capacity capacity of the syringe when the piston is drawn back to its furthest functional position 3.5 f id uc i a l l i ne leading edge on the plunger stopper that is in conta

40、ct with and perpendicular to the syringe barrel and aligns with the zero marking on the syringe barrel when the piston is fully inserted 3.6 unit packaging packaging which has direct contact with the device and maintains the sterility of the product 3.7 user packaging packaging designed to contain o

41、ne or more unit packages or self-contained syringe units Note 1 to entry: Self-contained syringe units can be packed in multiple unit packs. 3.8 two-piece syringe syringe assembly comprises the barrel and piston, whereas plunger and plunger stopper form one component made of the same material 3.9 th

42、ree-piece syringe syringe assembly includes the barrel and piston, whereas plunger and plunger stopper are two separate components of different materials 3.10 nozzle cap sheath intended to physically protect the nozzle prior to use 3.11 plunger stopper component connected to the leading end of the p

43、lunger and seals the open end of the syringe barrel 3.12 self-contained syringe syringe with protective end caps i.e. plunger cap, and nozzle cap or needle cap (3.17) intended to maintain the sterility of the interior of the syringe 3.13 dead space residual volume of fluid left in syringe when the p

44、lunger stopper (3.11) is fully depressed 3.14 multiple unit pack multiple syringes packaged with a single seal that maintains the sterility of the product2 ISO 2017 All rights reserved ISO 7886-1:2017(E) 3.15 piston assembled component of plunger and plunger stopper (3.11) 3.16 b a r r e l f l a n g

45、 e s flanges that protrude from the barrel (also referred to as finger grips) to provide the user an ergonomic means of gripping the syringe during injection 3.17 needle cap or shield sheath intended to physically protect the needle prior to use 3.18 plunger device component which advances the plung

46、er stopper (3.11) to deliver the medicinal product 4 Nomenclature The nomenclature for the components of hypodermic syringes for single use is shown in Figure 1. ISO 2017 All rights reserved 3 ISO 7886-1:2017(E) Key 1 needle cap or shield (if used) 10 plunger cap 2 nozzle cap 11 barrel flanges (fing

47、er grips) 3 nozzle lumen 12 fiducial line 4 nozzle 13 nominal capacity 5 barrel 14 graduation lines 6 plunger stopper (3-piece only) 15 zero line 7 seals 16 needle tube 8 plunger 17 hub 9 push-button NOTE The figure is intended to be illustrative of the components of a syringe. The plunger stopper/p

48、lunger assembly can or cannot be of integral construction and can or cannot incorporate more than one seal. Figure 1 Schematic representation of hypodermic syringe for single use4 ISO 2017 All rights reserved ISO 7886-1:2017(E) 5 General requirements The general requirements are considered to be des

49、ign inputs for manufacturers. a) Syringes shall be free from defects affecting appearance, safety and performance for their intended use. Syringes with integrated or add-on sharps protection shall comply with ISO 23908. The syringes barrel flanges shall be of adequate size, shape and strength for the intended purpose. The design specifications for the barrel flanges shall be determined through risk analysis and confirmed through usability validation testing. The materials shall not cause the syringes to yield, under c