Стандарты ASTM. 14.01 Healthcare Informatics / Информатика в области здравоохранения

ASTM E1633-08(2013)

Действует

Standard Specification for Coded Values Used in the Electronic Health Record — 110 стр.

ASTM E1564-00(2019)

Действует

Standard Guide for Design and Maintenance of Low-Temperature Storage Facilities for Maintaining Cryopreserved Biological Materials — 3 стр.

ASTM E1565-00(2019)

Действует

Standard Guide for Inventory Control and Handling of Biological Material Maintained at Low Temperatures — 3 стр.

ASTM E1566-00(2019)

Действует

Standard Guide for Handling Hazardous Biological Materials in Liquid Nitrogen — 2 стр.

ASTM E2147-18

Действует

Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems — 7 стр.

ASTM E2888-12(2019)

Действует

Standard Practice for Process for Inactivation of Rodent Retrovirus by pH — 3 стр.

ASTM E3231-19

Действует

Standard Guide for Cell Culture Growth Assessment of Single-Use Material — 6 стр.

ASTM E2503-13(2020)

Действует

Standard Practice for Qualification of Basket and Paddle Dissolution Apparatus — 4 стр.

ASTM E3219-20

Действует

Standard Guide for Derivation of Health-Based Exposure Limits (HBELs) — 30 стр.

ASTM E3230-20

Действует

Standard Practice for Extraction of Particulate Matter from the Surfaces of Single-Use Components and Assemblies Designed for Use in Biopharmaceutical Manufacturing — 12 стр.

ASTM E2898-20a

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Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications — 7 стр.

ASTM E2891-20

Действует

Standard Guide for Multivariate Data Analysis in Pharmaceutical Development and Manufacturing Applications — 7 стр.

ASTM E2629-20

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Standard Guide for Verification of Process Analytical Technology (PAT) Enabled Control Systems — 7 стр.

ASTM F838-20

Действует

Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration — 7 стр.

ASTM E2500-20

Действует

Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment — 6 стр.

ASTM E2890-21

Действует

Standard Test Method for Determination of Kinetic Parameters and Reaction Order for Thermally Unstable Materials by Differential Scanning Calorimetry Using the Kissinger and Farjas Methods — 12 стр.

ASTM E2489-21

Действует

Standard Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs — 13 стр.

ASTM E3291-21

Действует

Standard Guide for Reliability Demonstration Testing — 22 стр.

ASTM E2555-21e1

Действует

Standard Practice for Factors and Procedures for Applying the MIL-STD-105 Plans in Life and Reliability Inspection — 24 стр.

ASTM E3264-21

Действует

Standard Guide for Homogeneity of Samples and Reference Materials Used for Inter- and Intra-Laboratory Studies — 32 стр.