Cov qauv kev nyab xeeb thoob ntiaj teb rau cov khaub ncaws tiv thaiv

Hauv kev ua lag luam niaj hnub no thiab kev koom tes nrog cov khoom lag luam rau cov neeg xa khoom, tsis yog ib qho tseem ceeb thiab cov qauv kev ntseeg siab rau cov neeg siv khoom.

1.Cov khaub ncaws tiv thaiv dab tsi?

Cov khaub ncaws tiv thaiv yog cov khoom tshwj xeeb tsim los thaiv cov hnav los ntawm kev lag luam xws li tshuaj lom neeg, chaw soj ntsuam, thiab kev noj qab haus huv thiab kev noj qab haus huv.

Saib cov ntsiab lus ntxivKev Lag Luam Tiv Thaiv Cover

2.Cov Qauv Txheej Txheem Thoob Ntiaj Teb rau Kev Tiv Thaiv Khaub Ncaws

European Union siv rau cov qauv EN cov qauv rau cov khaub ncaws pov thawj cov khaub ncaws, suav nrog:

• En 14126: Rau kev tiv thaiv biological phom xws li cov kab mob thiab cov kab mob .
• En 14605: Rau cov khaub ncaws ua kua-nruj tshuaj tiv thaiv khaub ncaws (hom 3 thiab ntaus 4) .
• En iso 13982-1: Rau kev tiv thaiv qhuav particle (hom 5) .
• Rau 13034: Rau kev tiv thaiv kev tiv thaiv kev phom sij (ntaus 6) .
• En 1149-5: Rau cov khaub ncaws electrostatic tiv thaiv siv hauv ib puag ncig tawg.

2.1Key European Cov Qauv: En 14126 Thiab PPE Cov Kev Cai

En 14126: {{{2003+ AC: 2004 tus qauv rau cov khaub ncaws tiv thaiv tawm tsam cov neeg sawv cev

Cov tau txais daim ntawv thov: Chaw soj ntsuam kho mob, kev tswj hwm roj ntsha, sib kis tau sib kis kabmob, npog ob lub khaub ncaws pov tseg thiab rov siv dua tshiab.
Cov Khoom Xeem Ntawv:

• Cov Hluav Taws Xob Ntshav Cov Ntshav Nkag (ISO 16603): Tsis muaj kev nkag mus nyob rau hauv 1 {.} siab (qib 2 lossis siab dua).
• Tus kab mob nkag mus rau kev sim (ISO 16604): Siv PHI-x174 bacteriophit rau Simulate muaj peev xwm tawm tsam 27Nm cov lus .
• Cov kab mob nkag mus nkag (ISO 22610): Tsis kam rau pathogens xws li Staphylococcus aureus .
• Aerosol Nkag Mus Kuaj (ISO 22611): Simulates Txoj kev sib kis ntawm pathogen-muaj aerosol hais .

Kev Tiv Thaiv Qib Theem:

• Ntaus 1-6: Cov lej qis dua qhia txog qib siab . hom kev tiv thaiv + biologation rau kev kho mob {}}
• Hom 5B: Tiv thaiv cov khoom tawm tsam (e {.}}}}, hmoov av), haum rau tsis-icu ib puag ncig.

Saib ntxivNtaus 3B / 4B / 5B / 6B Taped Seams Tshuaj Tiv Thaiv Npog

2.2 EU PPE kev cai (EU) 2016/425

Daim Ntawv Pov Thawj Yuav Tsum:

• CE Npav: Txhua cov khaub ncaws tiv thaiv tuaj rau EU yuav tsum muaj ntawv pov thawj los ntawm lub cev ceeb toom .
• Cov Ntaub Ntawv Kev Ua Haujlwm: Suav nrog kev xeem ntawv, kev ntsuam xyuas, cov txheej txheem kev xeem, thiab lwm yam}} Kev tswj kev tswj hwm zoo.
• Sau npe qauv: Yuav tsum qhia hom tiv thaiv (e {{.}}}}, hom 4b), cov ntaub ntawv CE, thiab lwm yam}

3.}} wb Cov Qauv:(Niosh / Astm / Ansi/ Ntawv)

U {. s} s} s. kev lag luam feem ua raws cov qauv no:

• NFPA 1999: National Cov Chaw Tiv Thaiv Hluav Taws Kub National Cov Hluav Taws Xob Kev Tiv Thaiv Xwm Ceev Kev Kho Mob .
• ASTM F1670 / F1671: Kev ntsuam xyuas rau hluavtaws cov ntshav nkag thiab cov kab mob ntshav tsis kam tiv taus .
• Niosh-ntawv pov thawjcov qauv kev tiv thaiv ua pa yog feem ntau ua khub nrog cov khaub ncaws tiv thaiv .
• Ansi / isea 101: Cov qauv tsim rau cov khaub ncaws pov tseg pov tseg .

3.1} Astm F1670 / F1671 txoj kev ntsuam xyuas txoj hauv kev rau cov khaub ncaws tiv thaiv khomob

• ASTM F1670: Cov ntshav hluavtaws cov ntshav nkag mus, xav tau tsis muaj nkag ntawm 13 {{{{}} siab} 8 feeb.
• ASTM F1671: PHI-X174 bacteriophage kev ntsuam xyuas nkag mus kom ntseeg tau kab mob kab mob {}}
• Ansi / Aami Pb70: Ua Kua Hlau Teeb Meem

Saib ntxivAnsi / Aami PB70 Theem 2 / Theem 3 phais tsho tshaj sab

3{{0 {}} FDA 510 (K) Cov Txheej Txheem Pov Thawj

Cov tau txais daim ntawv thov: Cov khaub ncaws tiv thaiv kev kho mob yog cais raws li cov khoom siv kho mob hauv FDA 510 (k.
 

Cov Kev Cog Lus:

1. Cov Khoom Muag Khoom: Paub meej tias yog cov cuab yeej siv kho mob hauv chav kawm II .
2. PREDICATIC SECTICAT Kev Xaiv Ntaus: Txheeb xyuas ib qho kev pom zoo cov khoom lag luam zoo sib xws (ua ntej ntaus) {.
3. Kev Tshaj Tawm: Suav cov ntaub ntawv xeem ua tau, kev ceeb toom biocompatibility, daim ntawv tsim qauv, thiab lwm yam.
4. Kev Ntsuam Xyuas FDA: Feem ntau yuav siv sijhawm li 3-6 hlis; A 510 (K) Tsab Ntawv Pom Zoo Tso Cai yog muab tso rau thaum dhau .

4. Lus Suav Cov Qauv: Gb 19082-2023} thiab International Mutual lees paub

Ua ib qho chaw tsim khoom lag luam thiab cov khoom lag luam, Tuam Tshoj tau tsim cov qauv hauv tebchaws txhua qhov:

• 19082-2009: Cov kev yuav tsum tau ua rau cov khaub ncaws tiv thaiv mob khaub ncaws .
• GB / T 24539-2009: Kev qhia txuj ci siab rau cov khaub ncaws tshuaj tiv thaiv tshuaj .
• GB / T 23462-2009: Cov qauv rau kev pom cov khaub ncaws tiv thaiv .
• 12014-2019: General Specifications rau cov khaub ncaws electrostatic tiv thaiv .

4.1 GB 19082-2023} Cov Khaub Ncaws Khomob

Cov tshiab tshiab:

• Qhov ntsuas tshiab: Biocompatibility, seam zog, puas tsis kam .
• Tshem tawm cov ntsuas: Electrostatic lwj yuav tsum tau, streamlining qhov kev sim ua .
• Kev Sib Tham Thoob Ntiaj Teb: Sib npaug rau feem ntawm Eu Eu EN 1426 thiab peb astm f1670 / F1671, Enterping Cov Ntawv Pov Thawj Ua Si / FDA ntawv pov thawj rau kev nkag mus rau hauv cov lag luam thoob ntiaj teb {4

5. Australia TGA: Dual ua raws cai kev txiav thiab kev noj qab haus huv

• Kev tsim nyog tau txais txiaj ntsig: Cov khoom lag luam CE-cov khoom lag luam CE-{2-
• Kev Kawm Txog: Ib tug neeg xa khoom Suav tau ntsib ua / NZs 4381: 2001 Daim Ntawv Qhia Deb Tiv Thaiv TGA ntawm PE Australian Hlau Mines {{}

6. Tus Qauv Japanese: JIS T 8122 thiab Kev Lag Luam Kev Lag Luam

JIS T 8122: 2015 Txheem rau cov khaub ncaws tiv thaiv kev phom sij biological

Kev xav tau:

• Cov ntshav hluavtaws nkag (JIS T 8060): Tsis muaj nkag mus rau hauv qab 1 .} 75 kpa mev.
• Phoage Mus (JIS T 8061): Sim siv PHI-x174 bacteriophage.
• Tshuaj Tiv Thaiv Tshuaj (JIS T 8115): Dlej nrog rau 14605, muaj feem rau tshuaj thiab kho mob kho mob.
• Cov Txheej Txheem Pov Thawj: Yuav tsum tau sim los ntawm Japanese daim ntawv pov thawj lub cev (e {{{}}}}, dav hlau) kom tau txais JIS Mark .

{{07. bead-} Cov tswv yim kev lag luam kev lag luam thiab kev tsim tawm thev naus laus zis

{{0 {}}} cov khoom siv xaiv: Scenario-tshwj xeeb cov kev daws teeb meem

• Kev Kho Mob Siv: Ua ntej SMS nonwoven (Breatability ntau dua los yog sib npaug nrog En 14b-zoo rau cov neeg lag luam cov neeg saib xyuas kev noj qab haus huv {}}
• Kev Siv Siv: PTFE-laminated cov ntaub ntawv (200℃kub tsis kam) ntsib ttm f1670 qib 4 thiab NFPA 1999 nplaim taws tsis kam {}
• Siv: FDA-lees paub LDPE ua raws li 21 CFR 177 {{{}} 1520 rau kev sib cuag kev noj zaub mov.

2. Daim ntawv pov thawj Bundling: Txo cov nqi nkag thoob ntiaj teb

• CE + FDA Synchronized daim ntawv thov: Muab cov ntawv tshaj tawm ntaub ntawv tshaj tawm (E {.}!} {1% rau lub sijhawm lav thiab cov nqi.
• Kev sib ncaim hauv cheeb tsam hauv cheeb tsam hauv cheeb tsam: Leverage TGA lees txais ntawm CE rov qab nkag mus rau New Zealand thiab Mid G}, Saudi SFDA paub CE).

3. thev naus laus zis txuas

• Ntse Tiv Thaiv Suits: Ua ke nrog iot sensors (iso {13485-}}}}}}}}} Kev Noj Qab Haus Huv, tau sim ua German Icus.
• Cov Ntaub Ntawv Txawv Txiav Txim: PLA / PHA Composite nonwoven, muaj ntawv pov thawj raws EU (EU) 2019/904, degrades hauv<180 days, securing medical orders from the Netherlands and Sweden.

8. VIM LI CAS KHWV XAIV COV KHW YUAV TSUM TAU cov qauv thoob ntiaj teb?

• Lav ruaj ntseg

Cov qauv thoob ntiaj teb tau tshawb fawb txog kev ua tau zoo thiab kev tiv thaiv.

• Ua raws li cov kev cai

Cov khoom yuav tsum tau raws li cov kev cai zoo li CE (EU), FDA lossis Niosh (U .} 2.

• Kev Txhim Kho Hom Trust

Cov neeg siv khoom muaj peev xwm ntseeg siab dua yuav ntseeg tus neeg xa khoom uas muab ntawv pov thawj, cov khoom lag luam siab .

• Txo kev pheej hmoo

Cov khoom lag luam pov thawj txo cov kev pheej hmoo kev lag luam hauv kev tshwm sim ntawm kev phom sij ua haujlwm .

9. VIM LI CAS DAB TSI LI LIMCAR GROUP?

1. Yuav ua li cas peb thiaj li ua raws li cov qauv thoob ntiaj teb?

Ua ib qho chaw tsim khoom lag luam thiab cov khoom siv tshwj xeeb ntawm cov khaub ncaws tiv thaiv, peb paub tseeb tias zoo los ntawm:

• Cov Khoom Siv Raw Xaiv: Siv cov khoom tsim nyog nonwoven ntaub thiab PE txheej txheej;
• Kev Tswj Ntau Lawm: Ua raws li ISO 13485 thiab ISO 9001 lub nruab;
• Kev sim thib peb: Ua haujlwm nrog cov tub ceev xwm zoo li SGS, intertek rau cov ntawv pov thawj;
• Kev Xeem Ua Ntej: Hauv chav kuaj mob hauv tsev rau cov kua dej tsis haum, kev ua haujlwm tiv thaiv zoo li qub, thiab lub zog tensile.

2. Daim ntawv pov thawj peb tuav:
✅ EU TE (en 14126 +} er 14325)
✅ US FDA & ANSI / PB70
✅ Suav Teb NMPA Hoob II Doftware cuab yeej
✅ ISO 13485 & ISO 9001 Txheej Txheem Zoo

3. Xaiv peb rau:
✅ Puv-Kev Lag Luam Kev Lag Luam: Customized txheem sib xyaw rau txhua qhov xwm txheej .
✅ Ib-nres ntawv pov thawj: End-to-to-xaus kev txhawb nqa los ntawm cov khoom xeem rau ntau lub teb chaws sau npe {}}}}
✅ Qeb thev naus laus zis tsim kho: Lub sij hawm paub tseeb ntawm ISO / Astm hloov tshiab (e .}}}} dua} {{5}

Xaus: Ua txhaum txhais tau tias muaj kev nyab xeeb

Cov khaub ncaws tiv thaiv tsis yog zoo li qub-nws yog cov kev tiv thaiv kev nyab xeeb, kev muaj kev phom sij hauv ntiaj teb thiab cov khoom lag luam thoob ntiaj teb, peb cov khoom lag luam sib txawv, thiab 1149, thiab 1073, ASTM PB70, thiab ISO 9001 & ISO 13485, nrog rau cov kev daws teeb meem npog thoob ntiaj teb - Koj tus neeg sib tw sib tw npog cov chaw muab pov tseg ntawm cov neeg muab kev pab cuam tshuam nrog cov neeg muab kev pab cuam.