{"id":464787,"date":"2024-10-20T10:36:54","date_gmt":"2024-10-20T10:36:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-8871-22020-2\/"},"modified":"2024-10-26T19:34:19","modified_gmt":"2024-10-26T19:34:19","slug":"bs-en-iso-8871-22020-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-8871-22020-2\/","title":{"rendered":"BS EN ISO 8871-2:2020"},"content":{"rendered":"

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.<\/p>\n

The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Tests
4.1 General
4.2 Hardness
4.3 Density <\/td>\n<\/tr>\n
11<\/td>\n4.4 Ash
4.5 Infrared spectrum
4.5.1 Material
4.5.2 Coating
4.6 Compression set
4.7 Swelling
4.8 Development of a fingerprint by gas chromatography <\/td>\n<\/tr>\n
12<\/td>\n4.9 Detection of volatile substances by gas chromatography
4.10 Determination of residual moisture
4.11 Determination of fingerprint by thermogravimetric analysis (TGA)
4.12 Determination of extractables in aqueous autoclavates
5 Preparation of samples for testing
5.1 Treatment before testing
5.2 Number of samples needed for the tests <\/td>\n<\/tr>\n
13<\/td>\n6 Reagents and materials <\/td>\n<\/tr>\n
14<\/td>\nAnnex A (informative) Identification of elastomeric material by pyrolysis IR <\/td>\n<\/tr>\n
16<\/td>\nAnnex B (informative) Determination of compression set <\/td>\n<\/tr>\n
18<\/td>\nAnnex C (informative) Swelling behaviour in oils <\/td>\n<\/tr>\n
20<\/td>\nAnnex D (informative) Development of a fingerprint by gas chromatography <\/td>\n<\/tr>\n
22<\/td>\nAnnex E (informative) Analysis of volatile components by headspace gas chromatography <\/td>\n<\/tr>\n
24<\/td>\nAnnex F (informative) Determination of residual moisture <\/td>\n<\/tr>\n
25<\/td>\nAnnex G (informative) Determination of a fingerprint by thermal gravimetry (TG) <\/td>\n<\/tr>\n
28<\/td>\nAnnex H (informative) Determination of the elastomer identity and verification of the presence of a coating by surface infrared spectroscopy [attenuated total reflection (ATR)] <\/td>\n<\/tr>\n
31<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Elastomeric parts for parenterals and for devices for pharmaceutical use – Identification and characterization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2024<\/td>\n32<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":464798,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[138,2641],"product_tag":[],"class_list":{"0":"post-464787","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-20","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/464787","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/464798"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=464787"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=464787"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=464787"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}