{"id":386767,"date":"2024-10-20T03:36:56","date_gmt":"2024-10-20T03:36:56","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-13408-62021-tc\/"},"modified":"2024-10-26T06:36:17","modified_gmt":"2024-10-26T06:36:17","slug":"bs-en-iso-13408-62021-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-13408-62021-tc\/","title":{"rendered":"BS EN ISO 13408-6:2021 – TC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\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
1<\/td>\n30446295 <\/td>\n<\/tr>\n
65<\/td>\nA-30361786 <\/td>\n<\/tr>\n
66<\/td>\nNational foreword <\/td>\n<\/tr>\n
70<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
72<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 90\/385\/EEC [OJ L 189] aimed to be covered <\/td>\n<\/tr>\n
74<\/td>\nAnnex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
76<\/td>\nAnnex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98\/79\/EC [OJ L 331] aimed to be covered <\/td>\n<\/tr>\n
78<\/td>\nAnnex ZD (informative) Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
81<\/td>\nAnnex ZE (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/746 aimed to be covered <\/td>\n<\/tr>\n
85<\/td>\nForeword <\/td>\n<\/tr>\n
86<\/td>\nIntroduction <\/td>\n<\/tr>\n
87<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
89<\/td>\n4 Quality system elements
5 Basic principle of isolator systems
5.1 General <\/td>\n<\/tr>\n
90<\/td>\n5.2 Negative pressure isolators
6 Isolator system specification
6.1 General
6.2 Risk management
6.2.1 General <\/td>\n<\/tr>\n
91<\/td>\n6.2.2 Negative pressure isolator systems
6.3 User requirement specification
7 Design of isolator systems
7.1 General <\/td>\n<\/tr>\n
92<\/td>\n7.2 Materials of construction
7.3 Air-handling system
7.3.1 General
7.3.2 Air change rate
7.3.3 Airflow pattern <\/td>\n<\/tr>\n
93<\/td>\n7.3.4 Temperature\/humidity
7.3.5 Particulate air specifications
7.3.6 Recirculation of air
7.3.7 Pressure differentials
7.4 Operator interface
7.4.1 Isolator gloves\/sleeves <\/td>\n<\/tr>\n
94<\/td>\n7.4.2 Suits\/half-suits
7.4.3 Access to the isolator\/transfer systems
7.4.4 Devices acting as transfer ports <\/td>\n<\/tr>\n
95<\/td>\n7.5 Ancillary isolator equipment
7.5.1 Portable and mobile equipment
7.6 Surrounding room classification
7.7 Process utilities
8 Validation
8.1 General <\/td>\n<\/tr>\n
96<\/td>\n8.2 Design qualification
8.2.1 General
8.2.2 Product\/process application
8.2.3 Ergonomics
8.2.4 Cleaning <\/td>\n<\/tr>\n
97<\/td>\n8.2.5 Bio-decontamination
8.2.6 Selection of bio-decontamination agent
8.2.7 Development and validation of bio-decontamination processes <\/td>\n<\/tr>\n
98<\/td>\n8.2.8 Bio-decontamination agent generation and testing
8.2.9 Bio-decontamination parameters <\/td>\n<\/tr>\n
99<\/td>\n8.2.10 Aeration and residue limits
8.2.11 Log reduction
8.2.12 Surface bio-decontamination of items <\/td>\n<\/tr>\n
100<\/td>\n8.2.13 Development and validation of sterilization processes
8.3 Installation qualification
8.3.1 General
8.3.2 Installation <\/td>\n<\/tr>\n
101<\/td>\n8.4 Operational qualification
8.5 Performance qualification
8.5.1 General <\/td>\n<\/tr>\n
102<\/td>\n8.5.2 Cleaning
8.5.3 Bio-decontamination
8.5.4 Process simulation tests
8.6 Review and approval of validation
8.7 Requalification <\/td>\n<\/tr>\n
103<\/td>\n9 Routine monitoring and control
9.1 Procedures
9.2 System integrity
9.3 Bio-decontamination process monitoring <\/td>\n<\/tr>\n
104<\/td>\n9.4 Environmental monitoring
9.5 Change control
9.6 Maintenance and calibration
10 Personnel training <\/td>\n<\/tr>\n
106<\/td>\nAnnex A (informative) Devices acting as transfer ports for portable and mobile equipment <\/td>\n<\/tr>\n
109<\/td>\nAnnex B (informative) Isolator system \u2014 Explanation of terms used and flow of air and material <\/td>\n<\/tr>\n
110<\/td>\nAnnex C (informative) Isolator system \u2014 Direct\/indirect product contact surfaces <\/td>\n<\/tr>\n
111<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Aseptic processing of health care products – Isolator systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2021<\/td>\n112<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":386772,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-386767","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","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\/386767","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\/386772"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=386767"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=386767"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=386767"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}