Page 147 - Assurance of Sterility for Sensitive Combination Products and Materials
P. 147

Package/container closures   129


                  ence Center, East Windsor, NJ, 1976.
                [4]  F.B. Kilmer, Modern Surgical Dressings, Am. J. Pharm. 69 (1897) 15.
                [5]  Senate and House of Representatives of the United States of America, Medical De-
                  vice Amendments of 1976, 1976.
                [6]  Allen, D., Looking back over 20  years of sterile medical packaging (Available at
                  http://www.packagingdigest.com/medical-packaging/looking-back-20-years-of-
                  sterile-medical-pkg-pmp). Pharmaceutical & Medical Packaging News, 2013. Janu-
                  ary/February 2013.
                [7]  U.S. Food & Drug Administration (FDA), The Food and Drug Administration’s quali-
                  ty system regulations for medical devices (QSRs), Handi-Regs #9603 Keystone Press,
                  Bradenton, FL, 1997, p. 44.
                [8]  European Committee for Standardization, EN 868-1:1997 Packaging materials and
                  systems for medical devices which are to be sterilized—Part 1. General requirements
                  and test methods. 1997.
                [9]  European Committee for Standardization, EN 868—Packaging for Terminally Ster-
                  ilized Medical Devices—Part 2: Sterilization Wrap–Requirements and Test Methods,
                  2009 (CEN: Brussels).
                [10]  European Committee for Standardization, EN 868 - Packaging for Terminally Ster-
                  ilized Medical Devices—Part 3: Paper for Use in the Manufacture of Paper Bags
                  (Specified in EN 868-4) and in the Manufacture of Pouches and Reels (Specified in
                  EN 868-5)—Requirements and Test Methods, 2009 (CEN: Brussels).
                [11]  European Committee for Standardization, EN 868 - Packaging for Terminally Ster-
                  ilized Medical Devices—Part 4: Paper Bags—Requirements and Test Methods, 2009
                  (CEN: Brussels).
                [12]  European Committee for Standardization, EN 868—Packaging for  Terminally
                    Sterilized Medical Devices - Part 6: Paper for Low Temperature Sterilization Process-
                  es - Requirements and Test Methods, 2009 (CEN: Brussels).
                [13]  European Committee for Standardization, EN 868—Packaging for Terminally Steri-
                  lized Medical Devices—Part 7: Adhesive Coated Paper for Low Temperature Sterili-
                  zation Processes—Requirements and Test Methods, 2009 (CEN: Brussels).
                [14]  European Committee for Standardization, EN 868—Packaging for Terminally Steri-
                  lized Medical Devices—Part 8: Re-Usable Sterilization Containers for Steam Sterilizers
                  Conforming to EN 285—Requirements and Test Methods, 2009 (CEN: Brussels).
                [15]  European Committee for Standardization, EN 868—Packaging for Terminally Steri-
                  lized Medical Devices—Part 9: Uncoated Nonwoven Materials of Polyolefines—Re-
                  quirements and Test Methods, 2009 (CEN: Brussels).
                [16]  European Committee for Standardization, EN 868 - Packaging for  Terminal-
                  ly Sterilized Medical Devices - Part 10: Adhesive Coated Nonwoven Materials of
                  Polyolefines - Requirements and Test Methods, 2009 (CEN: Brussels).
                [17]  Scholla, M.H., Medical Packaging: Achieving a Single Global Standard (available at: http://
                  www.mddionline.com/article/medical-packaging-achieving-single-global-standard),
                  in MDDI. 2004, Can. Underwrit.
                [18]  Council and European Parliament, Regulation (Eu) 2017/745 of the European Par-
                  liament and of the Council of 5 April 2017 on medical devices, amending Directive
                  2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and
                  repealing Council Directives 90/385/EEC and 93/42/EEC, in 2017/745, 2017. Brussels.
                [19]  M. Barbella, Artful adaption: packaging and sterilization providers must keep pace
                  with rapid change to innovate, grow and improve safety., in Medical Product Out-
                  sourcing, Rodman Publishing, 2014 (The: The Free Library).
                [20]  D. Allen, Combination products: What role does packaging play? in: Pharmaceutical
                  & Medical Packaging News, 2015.
                [21]  M.P. Drues, Combination Products 101: A Primer For Medical Device Makers, in
                  Med Device Online, 2014, pp. 1–4.
                [22]  J. Wiley, The Wiley Encyclopedia of Packaging Technology, John Wiley & Sons, New
   142   143   144   145   146   147   148   149   150   151   152