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pharmaceutical equipment

pharmaceutical equipment, Total:58 items.

In the international standard classification, pharmaceutical equipment involves: Pharmaceutics, Medical equipment, Rubber and plastics products.

Professional Standard - Machinery, pharmaceutical equipment

• JB/T 20158-2013 Pharmaceutical cleaning in place equipment
• JB/T 20091-2007 Guidance on validation of pharmaceutical machinery (equipment)

American Society for Testing and Materials (ASTM), pharmaceutical equipment

• ASTM E1567-93(2001) Standard Guide for Biopharmaceutical Facilities Architectural Design Considerations
• ASTM E3263-22 Standard Practice for Qualification of Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues

British Standards Institution (BSI), pharmaceutical equipment

• BS EN ISO 8871-2:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Identification and characterization
• BS EN ISO 8871-5:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use. Functional requirements and testing
• BS EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceuticals use - Determination of released-particle count
• BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Extractables in aqueous autoclavates
• BS EN ISO 8871-3:2004+A1:2019 Elastomeric parts for parenterals and for devices for pharmaceutical use. Determination of released-particle count

European Committee for Standardization (CEN), pharmaceutical equipment

• EN ISO 8871-2:2020 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
• EN ISO 8871-5:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)
• EN ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
• EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count
• EN ISO 8871-2:2004/A1:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
• EN ISO 8871-3:2004/A1:2019 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count - Amendment 1 (ISO 8871-3:2003/Amd 1:2018)
• EN ISO 8871-2:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (Incorporates Amendment A1: 2014)
• EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

International Organization for Standardization (ISO), pharmaceutical equipment

• ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
• ISO 8871-5:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
• ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
• ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
• ISO 8871-3:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count
• ISO 8871-2:2003/Amd 1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization; Amendment 1
• ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
• ISO 8871-3:2003/Amd 1:2018 Elastomeric parts for parenterals and for devices for pharmaceutical usePart 3:Determination of released-particle count

Association Francaise de Normalisation, pharmaceutical equipment

• NF S93-102-2:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization.
• NF S93-102-5:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5 : functional requirements and testing
• NF S93-102-1*NF EN ISO 8871-1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1 : Extractables in aqueous autoclavates
• NF S93-102-2/A1:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2 : identification and characterization - Amendment 1
• NF S93-102-3*NF EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3 : determination of released-particule count
• NF S93-102-4*NF EN ISO 8871-4:2006 Elastomeric parts for parenteral and for devices for pharmaceutical use - Part 4 : biological requirements and test methods

Korean Agency for Technology and Standards (KATS), pharmaceutical equipment

• KS P ISO 8871-2:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 2：Identification and characterization
• KS P ISO 8871-2:2017 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 2：Identification and characterization
• KS P ISO 8871-5:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use-Part 5:Functional requirements and testing
• KS P ISO 8871-3:2009 Elastomeric parts for parenterals and for devices for pharmaceutical use-Part 3:Determination of released-particle count
• KS P ISO 8871-4:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use－Part 4：Biological requirements and test methods
• KS P ISO 8871-1:2010 Elastomeric parts for parenterals and for devices for pharmaceutical use-Part 1:Extractables in aqueous autoclavates
• KS P ISO 8871-1:2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates

German Institute for Standardization, pharmaceutical equipment

• DIN EN ISO 8871-2:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003); German version EN ISO 8871-2:2004, text in German and English
• DIN ISO 8871-5:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005), text in German and English
• DIN EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003); German version EN ISO 8871-1:2004, text in German and English
• DIN EN ISO 8871-3:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003); German version EN ISO 8871-3:2004, text german and english
• DIN EN ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006); English version of DIN EN ISO 8871-4:2006-09
• DIN EN ISO 8871-2:2020 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
• DIN EN ISO 8871-5:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005); German version EN ISO 8871-5:2014
• DIN EN ISO 8871-5:2017 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016
• DIN EN ISO 8871-2:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003 + Amd.1:2005); German version EN ISO 8871-2:2004 + A1:2014

Lithuanian Standards Office , pharmaceutical equipment

• LST EN ISO 8871-2:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
• LST EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

CH-SNV, pharmaceutical equipment

• SN EN ISO 8871-2:2020 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

AENOR, pharmaceutical equipment

• UNE-EN ISO 8871-2:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003)
• UNE-EN ISO 8871-2:2005/A1:2014 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
• UNE-EN ISO 8871-1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, pharmaceutical equipment

• GB/T 15692.6-1995 Water for pharmaceutical use
• GB/T 28671-2012 Guidelines for pharmaceutical machinery validation
• GB/T 42354-2023 Pharmaceutical machinery (equipment) material selection guidelines
• GB/T 36036-2018 Verify guidance of cleaning and sterilization for pharmaceutical machinery

KR-KS, pharmaceutical equipment

• KS P ISO 8871-1-2021 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates

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