{"id":424960,"date":"2024-10-20T06:54:17","date_gmt":"2024-10-20T06:54:17","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-80369-32016a12019\/"},"modified":"2024-10-26T13:00:04","modified_gmt":"2024-10-26T13:00:04","slug":"bs-en-iso-80369-32016a12019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-80369-32016a12019\/","title":{"rendered":"BS EN ISO 80369-3:2016+A1:2019"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | European foreword <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Table \u2014 Correlations between normative references and dated EN and ISO\/IEC standards <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Annex ZA (informative) Relationship between this document and the Essential Requirements of EU Directive 93\/42\/EEC Table ZA.1 \u2014 Correspondence between this document and Directive 93\/42\/EEC <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Table ZA.2 \u2014 Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006\/42\/EC on machinery that are addressed by this document <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Blank Page <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1 * Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4 General requirements 4.1 General requirements for the enteral application 4.2 Material used for enteral small-bore connectors <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 4.3 Type tests 5 Dimensional requirements for enteral small-bore connectors 6 Performance requirements 6.1 Fluid leakage 6.1.1 Fluid leakage requirement 6.1.2 Leakage by pressure decay 6.1.3 Positive pressure liquid leakage 6.2 Stress cracking 6.3 Resistance to separation from axial load <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 6.4 Resistance to separation from unscrewing 6.5 Resistance to overriding 6.6 Disconnection by unscrewing <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Annex A (informative) Rationale and guidance <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | Annex B (normative) Enteral small-bore connectors <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | Annex C (normative) Reference connectors <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | Annex D (informative) Assessment of medical devices and their attributes with connections within this application <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | Annex E (informative) Summary of the usability requirements for small-bore connectors for enteral applications <\/td>\n<\/tr>\n | ||||||
39<\/td>\n | Annex F (informative) Summary of small-bore connector criteria and requirements for enteral applications <\/td>\n<\/tr>\n | ||||||
42<\/td>\n | Annex G (informative) Summary of assessment of the design of the connectors for enteral applications <\/td>\n<\/tr>\n | ||||||
48<\/td>\n | Annex H (informative) Reference to the essential principles <\/td>\n<\/tr>\n | ||||||
50<\/td>\n | Annex I (informative) Terminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n | ||||||
51<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Small-bore connectors for liquids and gases in healthcare applications – Connectors for enteral applications<\/b><\/p>\n |