The current status of domestic and foreign laws and regulations restricting the application of PVC i

According to reports, Germany and Austria have banned the use of PVC infusion sets from January 1, 2007; relevant US health authorities require infusion sets made of DEHP plasticized PVC to be clearly marked for users to choose; environmental protection agencies and some private companies The organization called for the ban on the use of PVC infusion sets; California proposed the AB 1108 decree in February this year, which is expected to be implemented on January 1, 2009. Its requirements are as follows: (1) The content of DEHP, DBP and BBP in all toys and childcare articles Not more than 0.1% (2) For all toys and childcare articles under three years old that can be put in a child's mouth, the content of DINP, DIDP and DNOP must not exceed 0.1%.

Japan conducted inspections and evaluations of products on the Japanese market at the Comprehensive Research Institute of Health, Labor, Science, and Safety in 2013. It pointed out that the clinical use of PVC medical devices should be paid attention to, and recommended that the following situations should not be used. Substitutes containing DEHP: sensitive populations such as infants and young children; pregnant women, lactating women and highly sensitive trauma patients; patients infused with fat-soluble drugs; patients using artificial lungs, heart transplantation, paracardiac tubes, and hemodialysis Wait.

In the European Union, the 1999/815/EEC Directive published in 1999 stated that among the polyvinyl chloride (PVC)-related children’s toys and related articles put into the mouth of a three-year-old child, the six plasticizers shall not exceed the limit of 0.1% (6) The plasticizers are: (2-ethylhexyl) phthalate DEHP, di-n-butyl phthalate DBP, butyl benzyl phthalate BBP, diisononyl phthalate DINP , Diisodecyl phthalate DIDP and di-n-octyl phthalate DNOP).

On December 27, 2005, the European Union issued a new directive 2005/84/EC with the following requirements: (1) In all toys and childcare articles, the content of DEHP, DBP and BBP must not exceed 0.1%. (2) The content of DINP, DIDP and DNOP for all toys and childcare articles that can be put in children's mouths shall not exceed 0.1%.

In Denmark, in addition to the six content requirements set by the European Union, the content of any other phthalate esters for toys and childcare articles used by children less than three years old must not exceed 0.05%.

In September 2000, China stopped the approval of the newly built PVC soft bag packaging infusion production line, and gradually eliminated large PVC infusion bags; infusion sets, blood bags, and various interventional catheters are still made of PVC; because they have not been found in terms of comprehensive performance and price A substitute material that can compete with PVC, PVC still dominates the disposable infusion set market.

The 2010 new edition of the China Food and Drug Administration's guidelines for the registration of disposable medical infusion sets has required the hazardous identification of soft PVC infusion tubes containing DEHP plasticizers. The Environmental Protection Industry Standard of the People’s Republic of China (HJ/T 209-2005) issued by the State Environmental Protection Administration requires that food packaging and children’s toys prohibit the use of soft PVC containing DEHP; China’s General Administration of Quality Supervision, Inspection and Quarantine October 25, 2005 Announcement No. 155 issued prohibits the use of soft PVC containing DEHP.

The Environmental Protection Agency of Taiwan, China, has listed DEHP, DBP, and DMP as the fourth category of toxic chemical substance control. DEHP is listed as the first category of toxic chemical substances, restricting its use.