Üretim standartları

EN 10088/2 – Raw material (strip) technical specification
ASTM A480 – General Requirements for raw material (strip)
ASTM A240 – Chromium and Chromium-Nickel Stainless Steel for Pressure Vessels
EN 10217/7 – General standard for tubes for pressure equipment
ASTM A249 – Welded Austenitic Steel Boiler, Superheater, Heat-Exchanger, and Condenser Tubes
ASTM A803 – Ferritic Stainless Steel Feedwater Heater Tubes
ASTM A908 – Stainless Steel Needle Tubing
ASTM A270 – Stainless Steel Sanitary Tubing
ASTM A312 – Stainless steel pipe for high-temperature and general corrosive service
ASTM A358 – Electric-fusion-welded stainless steel pipe for corrosive or high-temperature service
ASTM A554 – Stainless Steel Mechanical Tubing
EN 10296 – Stainless steel tubes for mechanical and general engineering purposes
EN 10312 – Stainless steel tubes for the conveyance of aqueous liquids
ASTM A632 – Stainless Steel Tubing (Small-Diameter)
ASTM A269 – Austenitic Stainless Steel Tubing for General Service
ASTM A778 – Unannealed Austenitic Stainless Steel Tubes
ASTM B751 – Nickel and Nickel Alloy Welded Tube
ASTM A530 – General Requirements for Specialized Carbon and Alloy Steel Pipe
ASTM A789 – Ferritic/Austenitic Stainless Steel Tubing
ASTM A790 – Ferritic/Austenitic Stainless Steel Pipe

ASTM:
A450

SEP:
1914 – 1925

EN:
10204 – 10893/1/2 – 8492 – 8493 – 8494 – 8495 – 1127 – 3651/2 – 10002/1 – 10028/7

DİREKTİF:
Tıbbi cihazlar hakkındaki 93/42/CEE sayılı DİREKTİF ve sonraki güncel.

ISO:
ISO 7885 – Dentistry – Sterile injection needles for single use
ISO 9626 – Stainless steel needle tubing for the manufacture of medical devices
ISO 10993/1 – Biological evaluation of medical devices

EN:
EN ISO 11137/1/2/3 – Sterilization of health care products – Radiation
EN ISO 11135 – Sterilization of health care products – Ethtylene oxide
ISO 14971 – Application of risk management to medical devices
CEI EN 1041 – Information supplied by the manufacturer of medical devices
EN 556/1 – Requirements for medical devices to be designated “STERILE”
EN ISO 15223/1 – Symbols to be used with medical device labels, labelling and information to be supplied
EN ISO 11607/1/2 – Packaging for terminally sterilized medical devices

CEE DİREKTİFLERİ:

• 2006/42/CE “Makine Direktifi”;
• 2004/108/CE “Elektromanyetik uyumluluk”;
• 2006/95/CE “Alçak gerilim direktif”;

UYUMLAŞTIRILMIŞ STANDARTLAR:

• UNI EN ISO 12100:2010
  MAKİNE EMNİYETİ
  Tasarım için genel prensipler – Risk değerlendirmesi ve risk azaltılması
• UNI ISO/TR 14121-2:2010
  MAKİNE EMNİYETİ
  Risk değerlendirmesi – Bölüm 2: Pratik rehber ve yöntem örnekleri
• UNI EN ISO 13857:2008
  MAKİNE EMNİYETİ
  Kol ve bacakların ulaşabileceği bölgelerde tehlikenin önlenmesi için güvenlik mesafeleri
• UNI EN 349:2008
  MAKİNE EMNİYETİ
  İnsan vücuduna ait parçaların ezilmesini önlemek için minimum boşluklar
• UNI EN ISO 13850:2008
  MAKİNE EMNİYETİ
  Acil durumlarda durdurma teçhizatı – Tasarım prensipleri
• CEI EN 60204-1:2006
  MAKİNE EMNİYETİ
  Makinelerin elektrik donanımı
• UNI EN ISO 13849-1:2008
  MAKİNE EMNİYETİ
  Kumanda sistemlerinin güvenlikle ilgili kısımları – Bölüm 1: Tasarım için genel prensipler