Don't have a credit card? Never mind we support BANK TRANSFER .

Log inSign up
LANGUAGE en
Menu
STOREHelp centerContactsDelivery chargesABOUT US News
SEARCH
0
Total price
0 USD
PRICES include / exclude VAT
Homepage>UNE standards>UNE EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
in stockReleased: 2022-09-21
UNE EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

UNE EN ISO 13485:2018/A11:2022

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Productos sanitarios. Sistemas de gestión de la calidad. Requisitos para fines reglamentarios. (ISO 13485:2016).

Format
Availability
Price and currency
English PDF
Immediate download
118.02 USD
English Hardcopy
In stock
118.02 USD
Spanish PDF
Immediate download
98.35 USD
Spanish Hardcopy
In stock
98.35 USD
Standard number:UNE EN ISO 13485:2018/A11:2022
Pages:30
Released:2022-09-21
Status:Amendment
DESCRIPTION

This standard UNE EN ISO 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) is classified in these ICS categories:

  • 03.100.70
  • 11.040.01
Categories:
UNE standards
03.100.70 Management systems
11.040.01 Medical equipment in general
Print
Customers who bought this item also bought
Set of standards ISO 9000 ISO 9001 ISO 14001
Quality and Environment management systems
Released: 2015
ISO 9000 : 2015, ISO 9001 : 2015, ISO 14001 : 2015
English PDF
Immediate download
585.88 USD
English Hardcopy
In stock
585.88 USD
French PDF
Immediate download
585.88 USD
French Hardcopy
In stock
585.88 USD
Spanish PDF
Immediate download
585.88 USD
Spanish Hardcopy
In stock
585.88 USD
ISO 14971:2019
ISO 14971:2019-Medical devices — Application of risk management to medical devices
Released: 2019
English PDF
Immediate download
247.06 USD
English Hardcopy
In stock
247.06 USD
French PDF
Immediate download
247.06 USD
French Hardcopy
In stock
247.06 USD
UNE EN ISO 14644-2:2016
Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
Released: 2016-11-08
English PDF
Immediate download
107.15 USD
English Hardcopy
In stock
107.15 USD
Spanish PDF
Immediate download
89.29 USD
Spanish Hardcopy
In stock
89.29 USD
UNE EN ISO 14644-4:2023
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up (ISO 14644-4:2022)
Released: 2023-11-15
English PDF
Immediate download
189.46 USD
English Hardcopy
In stock
189.46 USD
Spanish PDF
Immediate download
157.88 USD
Spanish Hardcopy
In stock
157.88 USD