BS EN ISO 4074:2015 – TC:2020 Edition
$280.87
Tracked Changes. Natural rubber latex male condoms. Requirements and test methods
| Published By | Publication Date | Number of Pages |
| BSI | 2020 | 162 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 94 | European foreword |
| 95 | Table 1 — Correlation between normative references and dated EN and ISO or IEC standards |
| 96 | Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices |
| 100 | Foreword |
| 102 | Introduction |
| 104 | 1 Scope 2 Normative references 3 Terms and definitions |
| 106 | 4 Quality verification 5 Lot size |
| 107 | 6 Biocompatibility 7 Microbial contamination 8 Product claims 9 Design 9.1 Integral bead 9.2 Lubrication |
| 108 | 9.3 Dimensions 9.3.1 Length 9.3.2 Width 9.3.3 Thickness 10 Bursting volume and pressure |
| 109 | 11 Stability and shelf life 11.1 General 11.2 Minimum stability requirements |
| 110 | 11.3 Procedure for determining shelf life by real-time stability studies 11.4 Estimating shelf life based upon accelerated stability studies 12 Freedom from holes |
| 111 | 13 Visible defects 14 Package integrity of individual container 15 Packaging and labelling 15.1 Packaging 15.2 Labelling 15.2.1 General 15.2.2 Symbols 15.2.3 Individual container |
| 112 | 15.2.4 Consumer package |
| 114 | 15.2.5 Condoms not distributed in consumer packages 15.3 Inspection 16 Test report |
| 115 | Annex A (normative) Sampling plans intended for assessing compliance of a continuing series of lots of sufficient number to allow the switching rules to be applied |
| 117 | Annex B (informative) Sampling plans intended for assessing compliance of isolated lots |
| 119 | Annex C (normative) Determination of total lubricant for condoms in individual containers |
| 123 | Annex D (normative) Determination of length |
| 125 | Annex E (normative) Determination of width |
| 126 | Annex F (normative) Determination of thickness |
| 129 | Annex G (informative) Determination of microbial contamination |
| 134 | Annex H (normative) Determination of bursting volume and pressure |
| 136 | Annex I (normative) Oven treatment for condoms |
| 137 | Annex J (informative) Determination of force and elongation at break of test pieces of condoms |
| 140 | Annex K (normative) Determination of shelf life by real-time stability studies |
| 143 | Annex L (informative) Guidance on conducting and analysing accelerated ageing studies |
| 145 | Annex M (normative) Testing for holes |
| 151 | Annex N (normative) Testing for package integrity |
| 153 | Annex O (informative) Calibration of air inflation equipment for determination of bursting volume and pressure |
| 157 | Annex P (informative) Recommendations for testing condoms that fall outside of the size ranges specified in ISO 4074 |
| 159 | Bibliography |
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BS EN ISO 4074:2015
Natural rubber latex male condoms. Requirements and test methods Published By Publication Date Number of…
