ISO/TS 20399-1:2018 PDF
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
Biotechnology — Ancillary materials present during the production of cellular therapeutic products — Part 1: General requirements
- Статус документа:
- Отменён
- Формат:
- Электронный (PDF)
- Количество страниц:
- 10
- Дата публикации:
- 4 декабря 2018 г.
- Издание:
- ISO TS 20399 edition 1 version 1
- ICS:
- 07.080
This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.
Технические детали
- Технический комитет
- ISO/TC 276 - Biotechnology
- SKU
- ISO/TS 20399-1:2018
Похожие стандарты
Другие стандарты ISO
ISO 8689-1:2000
ДействующийWater quality — Biological classification of rivers — Part 1: Guidance on the interpretation of biological qu…
Overview ISO 8689-1:2000, titled Water quality - Biological classification of rivers - Part 1: Guidance on the interpretation of biological quality data from surveys of benthic macroinvertebrates, is…
ISO/ASTM51540-04(2012)
ОтменёнStandard Practice for Use of a Radiochromic Liquid Dosimetry System (Withdrawn 2020)
Significance and Use4.1 The radiochromic liquid dosimetry system provides a means of measuring absorbed dose in materials (5-7). Under the influence of ionizing radiation, chemical reactions take pla…
ISO/ASTM51204-04
ДействующийStandard Practice for Dosimetry in Gamma Irradiation Facilities for Food Processing (Withdrawn 2013)
Significance and Use4.1 Food products may be treated with ionizing radiation, such as gamma-rays from 60Co or 137Cs sources, for numerous purposes, including control of parasites and pathogenic micro…
ISO/ASTM51431-05
ОтменёнStandard Practice for Dosimetry in Electron Beam and X-Ray (Bremsstrahlung) Irradiation Facilities for Food P…
Significance and Use4.1 Food products may be treated with acceleratorgenerated radiation (electrons and X-rays) for numerous purposes, including control of parasites and pathogenic microorganisms, in…
ISO/ASTM52628-20e1
ДействующийStandard Practice for Dosimetry in Radiation Processing
1.1 This practice describes the basic requirements that apply when making absorbed dose measurements in accordance with the ASTM E61 series of dosimetry standards. In addition, it provides guidance o…
ISO/ASTM52921-13(2019)
ДействующийStandard Terminology for Additive Manufacturing—Coordinate Systems and Test Methodologies
Significance and Use 3.1 Although many additive manufacturing systems are based heavily upon the principles of Computer Numerical Control (CNC), the coordinate systems and nomenclature specific to CN…
ISO/ASTMTR52917-EB
ДействующийAdditive Manufacturing — Round Robin Testing — General Guidelines
This document outlines the steps with regard to aspects of design to conduct and run a round robin study (RRS) to assess the degree of variability in an additive manufacturing material or process. Th…
ISO/ASTM52901-17(2023)
ДействующийStandard Guide for Additive Manufacturing – General Principles – Requirements for Purchased AM Parts
Scope 1.1 This document defines and specifies requirements for purchased parts made by additive manufacturing. 1.2 It gives guidelines for the elements to be exchanged between the customer and the pa…