{"id":277899,"date":"2024-10-19T18:43:15","date_gmt":"2024-10-19T18:43:15","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-40742015\/"},"modified":"2024-10-25T15:14:48","modified_gmt":"2024-10-25T15:14:48","slug":"bs-en-iso-40742015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-40742015\/","title":{"rendered":"BS EN ISO 4074:2015"},"content":{"rendered":"
This International Standard specifies requirements and test methods for male condoms made from natural rubber latex.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Table 1 \u2014 Correlation between normative references and dated EN and ISO or IEC standards <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on Medical Devices <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 1\tScope 2\tNormative references 3\tTerms and definitions <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 4\tQuality verification 5\tLot size <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 6\tBiocompatibility 7\tMicrobial contamination 8\tProduct claims 9\tDesign 9.1\tIntegral bead 9.2\tLubrication <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 9.3\tDimensions 9.3.1\tLength 9.3.2\tWidth 9.3.3\tThickness 10\tBursting volume and pressure <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 11\tStability and shelf life 11.1\tGeneral 11.2\tMinimum stability requirements <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 11.3\tProcedure for determining shelf life by real-time stability studies 11.4\tEstimating shelf life based upon accelerated stability studies 12\tFreedom from holes <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 13\tVisible defects 14\tPackage integrity of individual container 15\tPackaging and labelling 15.1\tPackaging 15.2\tLabelling 15.2.1\tGeneral 15.2.2\tSymbols 15.2.3\tIndividual container <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 15.2.4\tConsumer package <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 15.2.5\tCondoms not distributed in consumer packages 15.3\tInspection 16\tTest report <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | Annex\u00a0A (normative) Sampling plans intended for assessing compliance of a continuing series of lots of sufficient number to allow the switching rules to be applied <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | Annex\u00a0B (informative) Sampling plans intended for assessing compliance of isolated lots <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | Annex\u00a0C (normative) Determination of total lubricant for condoms in individual containers <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | Annex\u00a0D (normative) Determination of length <\/td>\n<\/tr>\n | ||||||
35<\/td>\n | Annex\u00a0E (normative) Determination of width <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | Annex\u00a0F (normative) Determination of thickness <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | Annex\u00a0G (informative) Determination of microbial contamination <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | Annex\u00a0H (normative) Determination of bursting volume and pressure <\/td>\n<\/tr>\n | ||||||
46<\/td>\n | Annex\u00a0I (normative) Oven treatment for condoms <\/td>\n<\/tr>\n | ||||||
47<\/td>\n | Annex\u00a0J (informative) Determination of force and elongation at break of test pieces of condoms <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex\u00a0K (normative) Determination of shelf life by real-time stability studies <\/td>\n<\/tr>\n | ||||||
53<\/td>\n | Annex\u00a0L (informative) Guidance on conducting and analysing accelerated ageing studies <\/td>\n<\/tr>\n | ||||||
55<\/td>\n | Annex\u00a0M (normative) Testing for holes <\/td>\n<\/tr>\n | ||||||
61<\/td>\n | Annex\u00a0N (normative) Testing for package integrity <\/td>\n<\/tr>\n | ||||||
63<\/td>\n | Annex\u00a0O (informative) Calibration of air inflation equipment for determination of bursting volume and pressure <\/td>\n<\/tr>\n | ||||||
67<\/td>\n | Annex\u00a0P (informative) Recommendations for testing condoms that fall outside of the size ranges specified in ISO\u00a04074 <\/td>\n<\/tr>\n | ||||||
69<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Natural rubber latex male condoms. Requirements and test methods<\/b><\/p>\n |