We have a requirement for surgical gowns EN13795. The factory we are dealing with has confirmed that it is already certified for EN13485.
Do the gowns from an EN13485 certified factory automatically meet the 13795 requirement or do they need anything more to reach 13795?
Thank you for your help,
If gown's manufacturer does have certified ISO 13485, that does not mean automatically that gowns meet requirements from EN 13795. On manufacturer's Declaration of conformity must be stated to which standards gowns meet requirements.
EN 13795 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns is a standard that only describes which methods must be performed that certain gown can be properly prepared as a medical device.
Since ISO 13485:2016 is the only standard on the list of the harmonized standards that deals with the quality management system, it is expected that manufacturers have implemented this standard. Be aware that the MDR audit will always include the audit of the quality management system. So far, during MDD this was not the case, it was possible to audit separately ISO 13485 and MDD.
hello dear, i want to ask i a gown have iso 13485:2003 and EN iso 13485:2012/AC:2012 and FDA approval what does this means?? is this equivalenty to AAMI PB 70? and on which level of protection does this gown belong?
If your gown is produced under the ISO 13485:2003 and EN ISO 13485:2012/AC:2012, these standards are not valid any more. Ther eis new standard ISO 13485:2016 and manufacturers of the medicald evices should be in complaince with this version of the standard.
FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. Medical devices for specific medical conditions have to go through an approval process before getting to market (by checking the documentation, production process, performance and safety charactesristics).
„FDA approved“ means that agency has determined that the benefits of the product outweigh the known risks for the intended use. After the FDA approval, and only after it, it is possible to put the medical device on the market.
ANSI/AAMI PB70 - Class 3 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities" is a standard that descibes how gown must be constructed, and to which test it must respond. This standard can not be compared to the ISO 13485 because those two are different kind of standard.
AAMI PB70 is a technical standard, and ISO 13485 is a quality management standard. This means that manufacturer need to have defined processes and management system according to the ISO 13485, and that gown need to be constructed and produced to correspond to the AAMI PB70.
Level of protection for the gown depands on the construction of the gown, their intended use, type of the material.
If your gown is a class I medical device, you have to be in compliance with MDR 2017/7545 from May 26th 2021. This means that your technical documentation needs to be prepared according to Annex 2 and Annex 3 of the MDR.
Considering the ISO 13485, your certificate is valid until Feb 2022. However, be prepared that from May 26 2021 you need to prepare some additional documents that is required as part of quality management system required by MDR in Article 10, point 9. This refers to the strategy for regulatory management, UDI number identification, clinical evaluation process, and post-market surveillance process must also be part of your quality management system.