Medical Devices Rules 2017 follows ISO 14644-1:2015 standard. All catheters / IV Cannula / syringe etc. must be assembled in ISO Class 7 area, Component preparation shall be done in ISO Class 8 & Moulding shall be done in ISO Class 9 area.Final packing of sterile Surgical Dressing shall be done in ISO Class 9, In Vitro Diagnostic Kits does not require classified area.
Orthopedic Implants shall be cleaned and packed in ISO class 8 area if they are to be sterilized in Hospital. It’s very rare to sterilize implants in house however if required to be sterilized in house then they shall be cleaned and packed in ISO Class 7 area. For more details please click on the link below.
