BS EN 868-5-2009 Packaging for terminally sterilized medical devices - Sealable pouches and reels of porous and plastic film construction - Requirements and test methods《最终灭菌医疗器械的包.pdf

1、 ) *+*!“,-. !“ #$% Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods; Part 4: Paper bags Requirements and test methods; Part 5: Sealable pouches and reels of porous material

2、s and plastic film construction Requirements and test methods; Part 6: Paper for low temperature sterilization processes Requirements and test methods; Part 7: Adhesive coated paper for low temperature sterilization processes Requirements and test methods; Part 8: Re-usable sterilization containers

3、for steam sterilizers conforming to EN 285 Requirements and test methods; Part 9: Uncoated nonwoven materials of polyolefines Requirements and test methods; Part 10: Adhesive coated nonwoven materials of polyolefines Requirements and test methods. In addition, ISO/TC 198 “Sterilization of health car

4、e products“ in collaboration with CEN/TC 102 “Sterilizers for medical purposes“ has prepared the EN ISO 11607 series “Packaging for terminally sterilized medical devices“. The EN ISO 11607 series specifies general requirements for materials, sterile barrier systems and packaging systems (Part 1) and

5、 validation requirements for forming, sealing and assembly processes (Part 2). According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark

6、, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. BS EN 868-5:2009EN 868-5:2009 (E) 4 Introduction The EN ISO 1160

7、7 series consists of two parts under the general title “Packaging for terminally sterilized medical devices“. Part 1 of this series specifies general requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to mai

8、ntain sterility of terminally sterilized medical devices to the point of use. Part 2 of this series specifies validation requirements for forming, sealing and assembly processes. Every sterile barrier system shall fulfil the requirements of EN ISO 11607-1. The EN 868 series can be used to demonstrat

9、e compliance with one or more of the requirements specified in EN ISO 11607-1. During the revision of EN 868 parts 2 to 10 CEN/TC 102/WG 4 recognized Resolution CEN/BT 21/2003 relating to the implementation of the uncertainty of measurement concept in standards. Following this Resolution and the cor

10、responding guidance, CEN/TC 102/WG 4 has initiated a review of the test methods needed to show compliance with the requirements specified in EN 868 parts 2 to 10 with the intention that the information required by CEN/BT 21/2003 be available for inclusion in EN 868 parts 2 to 10 during one of their

11、next revisions. CEN/TC 102/WG 4 also appreciates the initiatives of CEN with regard to the minimization of adverse environmental impacts by standards. It was agreed that this subject should be given priority during the next edition of the EN ISO 11607 series that is the basic reference for all parts

12、 of the series EN 868. BS EN 868-5:2009EN 868-5:2009 (E) 5 1 Scope This part of EN 868 provides test methods and values for sealable pouches and reels manufactured from porous materials complying with either EN 868 part 2, 3, 6, 7, 9 or 10 and plastic film complying with Clause 4 used as sterile bar

13、rier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. NOTE 1 The need for a protective packaging may be determined by the manufacturer and the user. This part of EN 868 only introduces performance requirements and

14、test methods that are specific to the products covered by this part of EN 868 but does not add or modify the general requirements specified in EN ISO 11607-1. As such, the particular requirements in 4.2 to 4.5 can be used to demonstrate compliance with one or more but not all of the requirements of

15、EN ISO 11607-1. The materials specified in this part of EN 868 are intended for single use only. NOTE 2 When additional materials are used inside the sterile barrier system in order to ease the organization, drying or aseptic presentation (e.g. inner wrap, container filter, indicators, packing lists

16、, mats, instrument organizer sets, tray liners or an additional envelope around the medical device) then other requirements, including the determination of the acceptability of these materials during validation activities, may apply. 2 Normative references The following referenced documents are indi

17、spensable for the application 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. EN 868-2, Packaging for terminally sterilized medical devices Part 2: Sterilization wrap Req

18、uirements and test methods EN 868-3, Packaging for terminally sterilized medical devices Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods EN 868-6, Packaging for terminally

19、 sterilized medical devices Part 6: Paper for low temperature sterilization process Requirements and test methods EN 868-7, Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes Requirements and test methods EN 868-9, Packaging

20、for terminally sterilized medical devices Part 9: Uncoated nonwoven materials of polyolefines Requirements and test methods EN 868-10, Packaging for terminally sterilized medical devices Part 10: Adhesive coated nonwoven materials of polyolefines Requirements and test methods EN ISO 11140-1, Sterili

21、zation of health care products Chemical indicators Part 1: General requirements (ISO 11140-1:2005) EN ISO 11607-1:2006, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006) ISO 8601, Data elements and

22、 interchange formats Information interchange Representation of dates and times BS EN 868-5:2009EN 868-5:2009 (E) 6 ASTM D 882:1995, Test Methods for Tensile Properties of the Thin Plastic Sheeting 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN ISO 11

23、607-1:2006 and the following apply. 3.1 healthcare facility location where patients are medically treated and/or medical devices are terminally sterilized EXAMPLE Hospital, dentist office, practitioner. 4 Requirements 4.1 General The requirements of EN ISO 11607-1 apply. NOTE 1 EN ISO 11607-1:2006,

24、5.1.4 refers to conditions during production and handling with respect to their impact on the product (e.g. electrostatic conductivity, bioburden if applicable). NOTE 2 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2. 4.2 Materials 4.2.1 Porous material Th

25、e porous material shall comply with the requirements of either EN 868 part 2, 3, 6, 7, 9 or 10. When the porous material is to be used to manufacture preformed sterile barrier systems intended to be irradiation sterilized only, requirements for wet strength properties or permeability to air need not

26、 apply. 4.2.2 Plastic film 4.2.2.1 The plastic film shall be a composite of two or more layers. When tested after the intended sterilization process in accordance with Annex B the plastics interply bond shall not separate nor become cloudy. 4.2.2.2 The plastic film shall be free from pinholes when t

27、ested in accordance with Annex C. 4.2.2.3 When examined by unaided normal or corrected vision in transmitted light (daylight or good artificial light) the plastic film shall be free from foreign matter and/or other imperfections that would adversely affect compliance with the requirements of 4.5. NO

28、TE Slight continuous surface irregularities arising from the extrusion of the plastic film is not regarded as a defect. 4.2.2.4 The plastic film shall be sealable to the porous material under the conditions specified by the manufacturer (see Clause 5, NOTE 1). 4.2.2.5 The breaking factor of the plas

29、tics film shall be not less than 20 N per 15 mm width when tested in accordance with ASTM D 882:1995 (Method A). BS EN 868-5:2009EN 868-5:2009 (E) 7 4.3 Construction and design 4.3.1 Reel material shall be constructed from one layer of porous material and one layer of plastics film, sealed together

30、along parallel sides. Pouches shall be constructed from one layer of porous material and one layer of plastic film by sealing three sides and may include an area to effect closure of the pouch. 4.3.2 The overall width of the seal(s) shall be not less than 6 mm. For ribbed seals, the sum of the width

31、s of the ribs shall be not less than 6 mm. 4.3.3 The distance between the end of a pouch and the nearest edge of the width wise seal shall be sufficient to enable the two webs to be separated and peeled apart. NOTE The side seals can extend beyond the width wise seal to the end of the pouch provided

32、 that this does not impair peelability. 4.3.4 One of the materials of a pouch shall: a) be provided with a thumb notch not more than 12 mm deep at either the top or bottom of the pouch or at both ends. The bottom of the notch shall be at least 1 mm from the seal; or b) be lipped such that the length

33、 of one web is greater than the length of the other web by not less than 1,0 mm. 4.3.5 The pouch and/or reel shall be closed according to the manufacturers instructions. NOTE 1 For validation requirements for forming, sealing and assembly processes, see EN ISO 11607-2. NOTE 2 The closure and or seal

34、ing system may give the possibility to indicate whether or not the seal has been opened. 4.4 Process indicator If one or more Class I indicator(s) (process indicator(s) are printed on the pouches and tubes, the indicators performance shall comply with the requirements of EN ISO 11140-1. Each individ

35、ual indicator shall be not less than 100 mm in area. Indicators shall not be affected by the sealing procedure. 4.5 Performance requirements and test methods 4.5.1 When tested in accordance with the method described in Annex D the strength of the seal joint shall be not less than required for the in

36、tended purpose, both before and after being subjected to the sterilization process. NOTE 1 The specification for seal strength before and after exposure to sterilization processes can differ. Minimum value for seal strength in (healthcare facility) shall be 1,5 N per 15 mm for steam sterilization pr

37、ocesses and 1,2 N per 15 mm for other sterilization processes. NOTE 2 For applications outside healthcare facilities, requirements are given in EN ISO 11607. Report whether the tail was supported or unsupported, see D.6. 4.5.2 The seal shall be continuous and cover the specified width. There shall b

38、e no disruption of the surface of the porous material adjacent to the seal lines upon opening. Compliance shall be tested in accordance with Annex E. BS EN 868-5:2009EN 868-5:2009 (E) 8 4.5.3 For paper according to EN 868-3 and EN 868-6 the direction of the peel marked on the product shall correspon

39、d to that direction which ensures least fibre disturbance. Compliance shall be tested in accordance with Annex F. 4.6 Marking 4.6.1 Pouches and reels 4.6.1.1 Pouches and reel material shall be clearly marked with the following information unless agreed otherwise between the supplier and the customer

40、: a) the words “Do not use if the sterile barrier system is damaged“ or other equivalent phrase; b) lot number1; c) the manufacturers name or trade name; d) process indicator(s) if applicable; e) the direction of peel which will ensure the least fibre tear for reels; f) nominal dimensions and/or ide

41、ntification code. 4.6.1.2 The product shall not be printed on any surface which is designed to come into direct contact with the items to be packaged. 4.6.1.3 For lot number, process indicator, peel direction, and nominal dimensions or identification code (see 4.6.1.1 b), d), e) and f), the print re

42、peat interval on reel material shall be not greater than 155 mm. For other information mentioned in 4.6.1.1 a) and c), the print repeat interval shall be not greater than 310 mm. 4.6.2 Protective packaging Each unit of the protective packaging shall be legibly and durably marked with the following i

43、nformation: a) description of contents including the size, or/and an identification code, for the pouch or reel and reference to this Standard; b) quantity; c) the manufacturers or suppliers name or trade name, and address; d) date of manufacture in accordance with ISO 8601; e) lot number1; f) the r

44、ecommended storage conditions. 5 Information to be supplied by the manufacturer The manufacturer shall supply instructions for recommended sealing and/or closure conditions and for the monitoring of critical parameters of seal and/or closure integrity. NOTE 1 For validation of closure and sealing co

45、nditions, see EN ISO 11607-2. 1 A reference number in order to trace the manufacturing history of the product. BS EN 868-5:2009EN 868-5:2009 (E) 9 NOTE 2 For heat seals these parameters include the range of temperature, pressure and time. NOTE 3 For requirements on information to be provided by the

46、manufacturer national or regional legislation can apply, see in particular Directive 93/42/EEC, Annex I, Section 13. BS EN 868-5:2009EN 868-5:2009 (E) 10 Annex A (informative) Details of significant technical changes between this European Standard and the previous edition Changes between this Europe

47、an Standard and EN 868-5:1999 are the following: a) changes in order to align this European Standard with the series EN ISO 11607, in particular by: 1) amending the main element of the title, the scope and the terminology; 2) using EN ISO 11607-1 as normative reference regarding the general requirem

48、ents for materials, sterile barrier systems and packaging systems; 3) deleting requirements that are covered by EN ISO 11607 (such as requirements on leaching of toxic substances); b) in addition to a) first dash, the scope has been modified to: 1) explain that other requirements might be of relevance for additional materials being used inside a sterile barrier system; 2) clarify that the materials covered by this European Standard are intended for sing