EN ISO 13127-2012 en Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems《包装 儿童耐药包装机械包装系统测试方法能重新盖紧的孩子的抵抗力》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationPackaging Child resistantpackaging Mechanical testmethods for reclosable childresistant packaging systemsBS EN ISO 13127:2012BS EN ISO 13127:2012Incorporating corrigendum Decembe

2、r 2012BS EN ISO 13127:2012 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 13127:2012. It isidentical to ISO 13127:2012, incorporating corrigendum December 2012.The UK participation in its preparation was entrusted by Technical CommitteePKW/0, Packaging, to

3、Subcommittee PKW/0/3, Child Resistant Packaging.A list of organizations represented on this subcommittee can be obtainedon request to its secretary.This publication does not purport to include all the necessary provisions of acontract. Users are responsible for its correct application. The British S

4、tandards Institution 2013.Published by BSI Standards Limited 2013.Amendments/corrigenda issued since publicationDate Text affectedISBN 978 0 580 81353 5ICS 55.020Complicance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority

5、of the Standards Policy and Strategy Committee on 28 February 2013.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13127 October 2012 ICS 55.020 English Version Packaging - Child resistant packaging - Mechanical test methods for reclosable child resistant packaging systems (ISO 13127:2012)

6、Emballages - Emballages lpreuve des enfants - Mthodes dessais mcaniques pour systmes demballage refermables lpreuve des enfants (ISO 13127:2012) Verpackung - Kindergesicherte Verpackung - Mechanische Prfverfahren fr wiederverschliebare kindergesicherte Verpackungssysteme (ISO 13127:2012) This Europe

7、an Standard was approved by CEN on 30 September 2012. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references c

8、oncerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member

9、 into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, Franc

10、e, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOM

11、ITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13127:2012: EBS EN ISO 13127:2012EN ISO 13127:2012 (E) 2 Contents Page Foreword 3BS EN ISO 13127:2012EN I

12、SO 13127:2012 (E) 3 Foreword This document (EN ISO 13127:2012) has been prepared by Technical Committee CEN/TC 261 “Packaging“, the secretariat of which is held by AFNOR, in collaboration with Technical Committee ISO/TC 122 “Packaging“. This European Standard shall be given the status of a national

13、standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights

14、. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyp

15、rus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the Unite

16、d Kingdom. BS EN ISO 13127:2012iiISO 13127:2012(E) ISO 2012 All rights reserved iiiContents PageIntroduction v1 Scope 12 Normative references . 13 Terms and definitions . 14 General requirements . 24.1 Rationale 24.2 Reference data . 24.3 Package modifications . 24.4 Testing facilities . 44.5 Test m

17、ethods 54.6 Test method selection 54.7 Component verification . 55 Samples . 55.1 Sample selection . 55.2 Sample preparation . 56 Testing 56.1 Applicability of tests . 56.2 Specific tests 66.3 Assessment of test results . 67 Test report . 67.1 General . 67.2 Test facility (name and address) . 67.3 A

18、pplicant (name and address) . 67.4 Report number . 77.5 Date . 77.6 Manufacturer . 77.7 Packaging description . 77.8 References 77.9 Test description and results . 77.10 Signature . 7Annex A (normative) Torque release test . 8Annex B (normative) Squeeze test 9Annex C (normative) Non-squeeze torque t

19、est 10Annex D (normative) Press down and turn engagement test 11Annex E (normative) Push and turn test 12Annex F (normative) Reverse ratchet torque test13Annex G (normative) Disassembly test 14Annex H (normative) Rotational torque test 17Annex I (normative) Push-off force 18Annex J (normative) Appli

20、cation force .19Bibliography .20BS EN ISO 13127:2012ivISO 13127:2012(E)IntroductionA significant number of suspected cases of ingestion by children of products used about the home is reported to the medical profession each year. Most are not serious and those that are associated with more serious si

21、de effects involve products known to be hazardous, e.g. certain medicinal products, liquid fuels and solvents, strongly acid or alkaline preparations and some garden products. Most commonly used household detergents, cleaning agents and maintenance and care products are not known to have caused inju

22、ry. However, whether ingestion (actual or suspected) causes injuries or not, such incidents can have traumatic effects on both the child and its parents.The use of potentially hazardous agents in certain products is necessary to achieve effectiveness; consequently steps have to be taken to limit the

23、 occurrence of accidents. One approach has been to try to increase general awareness of hazards associated with various products. Nevertheless, proper labelling and information by the manufacturer is important for the safe use of products in the home.Another approach has been the use of child resist

24、ant packaging to put a physical barrier between the child and the hazardous product. Such packaging should only be used for products as mentioned above since, if used in other circumstances, it could lead to confusion among consumers. It is important to recognize that it is unrealistic to expect tha

25、t any functional packaging can be totally impossible for a child to open and this type of packaging cannot be a substitute for normal safety precautions. The packaging functions as a last defence if other barriers separating children and hazardous products have failed. Hence, the overall responsibil

26、ity rests with the parents or other responsible adults.The aim of this International Standard is to establish mechanical test methods to safeguard child resistance properties of the packaging system.According to ISO 8317, the panel test is intended for initial type approval but it does not sufficien

27、tly cover change management.NOTE Change management covers, but is not limited to, for example, change of supplier, packaging material, component manufacturing site, material brand or scale up.Those changes need to be assessed using risk management procedures. Mechanical test methods deliver scientif

28、ic data which introduce a more scientific means of ensuring compliance with the originally type tested package. The test results are essential for an appropriate risk assessment.The object of this International Standard is to permit the comparison, by mechanical testing, of the physical parameters o

29、f the packaging system under test with those of the individual units tested for certification purposes. It is the responsibility of the component manufacturer to provide access to test methods and test data to the customer. ISO 2012 All rights reserved vBS EN ISO 13127:2012iv ISO 13127:2012(E)Introd

30、uctionA significant number of suspected cases of ingestion by children of products used about the home is reported to the medical profession each year. Most are not serious and those that are associated with more s rious side effects involve products known to be hazardous, e.g. certain medicinal pro

31、ducts, liquid fuel and solvents, strongly acid or alkaline preparations and some garden products. Most commonly used household detergents, cleaning agents and maintenance and care products are not known to have caused injury. How ver, whether ingestion (actual or suspected) causes injuries or not, s

32、uch incidents can have traumatic effects on both the child and its parents.The use of potentially hazardous agents in certain products is necessary to achieve effectiveness; consequently steps have to be taken to limit the occurrence of accidents. One approach has been to try to increase general awa

33、reness of hazards associated with various products. Nevertheless, proper labelling and information by the manufacturer is important for the safe use of products in the home.Another approach has been the use of child resistant packaging to put a physical barrier between the child and the hazardous pr

34、oduct. Such packaging should only be used for products as mentioned above since, if used in other circumstances, it could lead to confusion among consumers. It is important to recognize that it is unrealistic to expect that any functional packaging can be totally impossible for a child to open and t

35、his type of packaging cannot be a substitute for normal safety precautions. The packaging functions as a last defence if other barriers separating children and hazardous products have failed. Hence, the overall responsibility rests with the parents or other responsible adults.The aim of this Interna

36、tional Standard is to establish mechanical test methods to safeguard child resistance properties of the packaging system.According to ISO 8317, the panel test is intended for initial type approval but it does not sufficiently cover change management.NOTE Change management covers, but is not limited

37、to, for example, change of supplier, packagi g material, component manufacturing site, material brand or scale up.Those changes need to be assessed using risk management procedures. Mechanical test methods deliver scientific data which introduce a more scientific means of ensuring compliance with th

38、e originally type tested package. The test results are essential for an appropriate risk assessment.The object of this International Standard is to permit the comparison, by mechanical testing, of the physical parameters of the packaging system under test with those of the individual units tested fo

39、r certification pur oses. It is the responsibility of the component manufacturer to provide access to test methods and test data to the customer. ISO 2012 All rights reserved vBS EN ISO 13127:2012ISO 13127:2012(E)IntroductionA significant number of suspected cases of ingestion by children of product

40、s used about the home is reported to the medical profession each year. Most are not serious and those that are associated with more se ious side effects involve products known to be hazardous, e.g. certain medicinal products, liquid fu ls and solvents, strongly acid or alkaline preparations and some

41、 garden products. Most commonly used household detergents, cleaning agents and maintenance and care products are not known to have caused injury. However, whether ingestion (actual or suspected) causes injuries or not, such incidents can have traumat c effects on both the child and its parents.The u

42、se of potentially hazardous agents in certain products is necessary to achieve effectiveness; consequently steps have to be taken to limit the occurrence of accidents. One approach has been to try to increase g neral awareness of hazards associated with various products. Nevertheless, proper labelli

43、ng and information by the manufacturer is important for the safe use of products in the home.Another approach has been the use of child resistant packaging to put a physical barrier between the child and the hazardous product. Such packaging should only be used for products as mentioned above since,

44、 if used in other circumstances, it could lead to confusion among consumers. It is important to recognize that it i unrealistic to expect that any functional packaging can be totally impossible for a child to op n and his type of packaging cannot be a substitute for normal safety precautions. The pa

45、ckaging functions as a last defence if other barriers separating children and hazardous products have failed. Hence, the overall responsibility rests with the parents or other responsible adults.The aim of this International Standard is to establish mechanical test methods to safeguard child resista

46、nce properties of the packaging system.According to ISO 8317, the panel test is intended for initial type approval but it does not sufficiently cover change management.NOTE Change management covers, but is not limited to, for example, change of supplier, packaging material, component manufacturing s

47、ite, material brand or scale up.Those changes need to be assessed using risk management procedures. Mechanical test methods deliver scientific data which introduce a more scientific means of ensuring compliance with the originally type tested package. The test results are essential for an appropriat

48、e risk assessment.The object of this International Standard is to permit the comparison, by mechanical testing, of the physical parameters of the packaging system under test with those of the individual units tested for certification purposes. It is the responsibility of the component manufacturer t

49、o provide access to test methods and test data to the customer. ISO 2012 All rights reserved vBS EN ISO 13127:2012ISO 13127:2012(E)IntroductionA significant number of suspected ca es of ingestion by children of products used about the home is reported to the medical profession each year. Most are not serious and those th t are associated with more serious side ffects involve products known to be h zardous, e.g. certain medicinal products, liquid fu ls and solvents, strongly acid or alkaline prep rations and some garden products. Most co monly used

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