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BS EN ISO 13408-6:2021 Aseptic processing of health care products - Isolator systems, 2021
- National foreword
- European foreword
- Annex ZA (informative) Relationship between this European Standard and the essential requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered
- Annex ZB (informative) Relationship between this European Standard and the essential requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
- Annex ZC (informative) Relationship between this European Standard and the essential requirements of Directive 98/79/EC [OJ L 331] aimed to be covered
- Annex ZD (informative) Relationship between this European Standard and the General Safety and Performance requirements of Regulation (EU) 2017/745 aimed to be covered
- Annex ZE (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Quality system elements
- 5 Basic principle of isolator systems [Go to Page]
- 6 Isolator system specification [Go to Page]
- 7 Design of isolator systems [Go to Page]
- 8 Validation [Go to Page]
- 9 Routine monitoring and control [Go to Page]
- 10 Personnel training
- Annex A (informative) Devices acting as transfer ports for portable and mobile equipment
- Annex B (informative) Isolator system — Explanation of terms used and flow of air and material
- Annex C (informative) Isolator system — Direct/indirect product contact surfaces
- Bibliography [Go to Page]
