Shoulder Dystocia Injury: 3D Medical Animation
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The definition that sterilization of medical devices packs should understand for:
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Use at medical devices kind of the product pack, can have sterilization to its, can undertake aseptic manipulation (like clean open) , can offer acceptability microbial cut off function, sterilization around can make protect and can be after sterilization inside proper time to the product (tagged period of efficacy) the packing system that maintains environment of systematic interior asepsis. Because this concept does not include the protection outside to pack a system normally (amortize is packed and the part such as assembly packaging) , so sterilization of medical devices packs what the system also can say to be " system of asepsis protective screen (SterilizationBarrier System, SBS) " (the standard appellation according to ISO11607-2006) . Sterilization of medical devices is packed belong to a burgeoning development domain, can say to burgeoning industry is belonged to inside limits all over the world, in and still be in ceaseless accumulation be being summed up, the development in home especially slow. With the sealed packing data that requires sterilization medical devices at be opposite, have function of microbial protective screen, can prevent microbial enter and offer asepsis to defend, make the product is packed finally in the aseptic when using.
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English name: Sterilepouch
.The relevant code that sterilization of medical devices packs standard:
The code that packs about sterilization of medical devices standard, current, what worth while discussion is below these two: ISO11607 and EN868, of course these two belong to category of level of general rule sex, covered again inside them a lot of pack a system about sterilization of medical devices the relevant test standard of particular test method, basically be the standard such as ASTM and ISO!
ISO11607 shares 3 version so far, it is 1997 edition, 2003 edition are mixed respectively 2006 edition, also can seeing sterilization of medical devices packs this domain from here is new inside limits all over the world, according to the program, next version should be rolled out inside 5 years after 2006.
Newest 2006 edition, promulgate formally in April 2006, two parts are comprised, the first part basically is about packing material, asepsis to cut off the system is mixed of the system that pack, the craft that the 2nd part basically told about sterilization of concerned medical devices to pack affirms (Validation, similarly hereinafter) problem, pack asepsis so affirm with the craft that pack by design of the system that pack content of this two large principal part distinguishs came. More important is, in this version, absorb formally incorporated the EN868 standard system of European popularity, cancelled the system of general rule sex that EN868-1 conflicts this each other already, absorb optionally incorporated EN868-2 arrives - 10 these 9 are mixed about specific data of the product child standard, this also was proclaiming in fact the sterilization of medical devices with unified whole world packs a standard to was born 2006 eventually, already ISO11607-2006.
About EN868 this standard, standard of sex of this general rule also promulgates its original EN868-1 1997, ever since - 2 to - 10 are in as accessary standard ever since make up a few years slowly in time write development to rise, but as a whole the criterion that this fits sterilization to pack manufacturer to control material and production like more, is not the is used at coaching sterilization packs a system check mark that for medical devices manufacturer designs one allows, and this standard is done not have all the time fore-and-aft update, it is redo only some transverse child of the standard patulous!
What what I hope is, discuss concerned medical devices when us later when sterilization packs a standard, need to pay close attention to ISO11607 only this one standard! As to our country, 2005 coequal cited ISO11607-2003 as recommend sexual GB GB/T19633-2005, also doing the work that updates ISO11607-2006 translate into edition GB/T19633 all the time at present!
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.., can get used to corresponding sterilization process;
.., protector fetterses, make appliance maintains in acceptability use condition falls;
.., have a bacterium to cut off function, the asepsis sex of appliance and integrality can maintain before using;
.., can asepsis open, in order to use weapon;
.., identify correctly with use product.
. The principle pursues as follows:
......Quality technology asks:
1, include material to must cut off effectively microbial / bacterial ASTM F-1608
2, the sterilization means ISO11134\ISO11135\ISO11137 that must get used to acceptance
3, the asepsis position that maintains a product. Pack cannot have quite be polluted by air, fiber damaged, the exotic such as dirt, microbial invasive opportunity (ASTMD-.
2019).. Accordingly, pack need to ensure:
..- - include material not to have damaged;
..- - close complete, come off intensity (ASTM F88) appropriate, without permeate (ASTM
...
F1929:1998) , without blow up (ASTM F-1150 / ASTM F-2054) , come off clean
...
Clean (EN868-5) .
4, include material or pack follow-up Ying Yi at be being machined;
. Material makes when the reduces grain desquamation that needs the oldest rate, for example fiber, chip, printing ink falls off, dirt. (ASTM D-2019)
5, after the open that pack, due and apparent trace shows ever had been opened;
.After open of mouth of the open the envelop that pack, not due and aleatoric seal again add up to a gender. (precaution is packed open be added up to afresh again next by pollution)
6, should mark open position and direction;
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Answer to unseal easily, and unseal the position should go to the lavatory the person that use hits open (EN980)
7, must can admit fasten a product (presswork Ma head should accord with laws and regulations of cure appliance law to ask, include material to have the stuff with transparent one side, can see in-house yield
. Article) EN980
The category differentiates:
In order to anticipate utility differentiates
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- - the hospital is used (personalized requirement, make up operation combination to pack by oneself with; Repeatability makes
..........
Use with appliance sterilization; Sterilization of big appliance whole) ;
..- - dentistry clinic is used (repeatability uses weapon again sterilization is packed use) ;
..- - manufacturer is used (sterilization of one-time asepsis use product packs use) ;
..- - other, be like lab.
Differentiate with sterilization means
..- - sterilization of high temperature vapour
High Temperature Steam;
..- - irradiation Radiation sterilization - Gamma, electron Beam;
..- - aeriform sterilization Gaseous - Ethylene Oxide of sterilization of annulus oxygen ethane
..- - Low Temperature Oxidative - of microtherm oxidation sterilization crosses Sterrad of oxidation hydrogen sterilization.
Differentiate with product structure
. - - planar bag (use at ply small, standardize a product)
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- - canal bag (use at a variety of a few product, but aleatoric intercept length)
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- - stereo bag (use at ply tall, the product with irregular bulk)
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- - coming directly towards bag (use at the area big, weight is great, volume is large and the product with additional low cost)
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- - in envelope (use at asking to pack fatigue to originally and the product with additional low cost)
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- - lid material (use at with suck model box heat forcedly to close, suck the product that model packages forcedly)
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- - wrap up material (use at needing to disinfect wrap up, and the product that uses namely after disinfection)
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- - roll material (the data that is used at him automation sterilization to pack production)
Add up to means in order to seal to differentiate
..- - heat is sealed model
..- - Leng Feng / self-given model
Differentiate with agglutinate principle
..- - coating of the collosol that do not have heat sticks heat to close oneself
- - coating of glue of solvent sex thermosol - heat seals agglutinate
..- - coating of water-solubility thermosol glue - heat seals agglutinate
..- - coating of solvent sex cold collosol - pressure agglutinate
..- - coating of water-solubility cold collosol - pressure agglutinate
..- - rip profile easily to expect without coating - heat seals agglutinate
Differentiate with material permeability
..- - breathe freely (analyse) the gender packages data
..- - blame permeability packages data
Medical model of paper of disinfection of sterilization of medical devices wraps bagging - groovy material category
Surface ability
..- gelatinize is dialytic paper
- stick dialytic paper oneself
..- strengthen dialytic paper
..- Tyvek
- PET/ rips film easily
Bottom material
Drench velar paper, groovy structure is: Paper/PE
..
Compound film, groovy structure is: PET/PE, PET/CPP, opp/PE
..
Squeeze film in all, groovy structure is: Corona Layer, main Layer, heat Seal Layer
..
Soft film suction model, groovy structure is: PA/PE, PP/PE, PP/PA/PE, PA/PP, EVA/Surlyn/EVA
..
Suck model film forcedly, groovy structure is: PETG, APET, HIPS, PP.
Coating of surface ability paper pressworks paper + bottom material is dialytic paper, a kind of trend that makes manufacturing paper paper bag.
Sterilization of medical devices is packed - chemical indicator and presswork ink
1, sterilization becomes angry chemical indicator, this product is similar to presswork ink, treatment principle pressworks together Chinese ink, presswork its to be installed at the bag normally inside bag or exterior. Its principle is fall in specific sterilization requirement, indicator Yin Mo is become by initiative color beforehand the color of set. The function depends on indicating the sterilization condition that whether is sterilization product passed and accords with a regulation intuitionisticly. Sterilization becomes angry indicator divides chemistry to be mixed for ability in swimming oily, distinction is not containing heavy metal at ability in swimming.
2, presswork ink, normally cent is mixed for ability in swimming oily, be based on the quality requirement of medical treatment product, medical treatment is packed use bag of lake be surrounded by mountains knowledge normally, this ink should examine through ISO10993 biology compatibility, heavy metal content accords with IEC62321:2008, US EPA 3052:1996 requirements
The choice that sterilization of medical devices packs
The feature of appliance and requirement
- horniness (whether acute angle) , soft qualitative;
- regular, irregular sex;
- ply.
Sterilization requirement
- ETO;
- Steam
- Sterrad
- Gamma
The product assigns sold route
- before loading appliance, carry, still load
....Appliance hind is carried;
- carriage kind and carriage distance;
- the kind that cent sells, entire case, entire case is returned
....It is the smallest pack;
- outer packing requirement.
Ticket demand
- presswork to Ma head requirement;
- legal laws and regulations of place asks.
Level of the unit that pack
- manual ／ is automatic
- the quality of the equipment that pack and precision.
Cost
- quality is oriented;
- cost is oriented
Sterilization of medical devices is packed - groovy workmanship principle
Dialytic paper
..Net of shop of → of hydrolyze of → wood pulp, roller pressing, drying refines paper → receives a → cent to cut → to pack. (stick oneself with be not the main distinction that sticks paper oneself to be shape in papermaking in the process, bubble is invaded in the surface of paper industrial chemicals)
Compound film (compound machine)
..→ deserves to choose makings bead to → blows film or flow delay 2 into velar stuff → or become preelection film more compound and into.
Blow film in all agent or stream delay in all agent film (blow velar opportunity or flow delay machine)
..The photograph of 2 kinds of above sticks → → of dissolve makings bead is multilayer blow film or much laminar flow is delayed in all the agent shapes velar stuff → receives a → cent to cut → to pack.
Drench film (drench velar machine)
..→ is on paper or its base material, through drenching plastic particle velar equipment high temperature dissolves, the modular head small Kong Zhonglin that passes adjustable ply next is on base material, cool next shape.
Coating expects (spreader)
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→ is on paper or other base material, pass reticulation roller, the means move that the hot collosol that will dissolve beforehand presses through pressure roller arrives on base material, next stoving is caky.
Medical model of paper of disinfection of sterilization of medical devices wraps bagging - effectiveness affirms
(1)
ISO 11607:2006.
- of final asepsis medical devices pack;
ISO 11607-1: The system of protective screen of 2006 - material, asepsis, requirement with the system that pack; To packaging data, pack raise a requirement (replace EN 868Part 1)
ISO 11607-2: 2006- figuration, sealed acknowledge a demand with what rig a process; Hold equipment, production to the bag craft, with production moving process raises a requirement (IQ, OQ, PQ) , accord with a requirement in order to make sure every sterilization packages a product
(2)
ISO 11607 part 2
5.The process that pack admits really;
.....- 5.1 general principles;
.....- 5.2 installation appraisal (IQ -Installation Qualification) ;
.....- 5.3 moving appraisal (OQ -Operational Qualification) ;
.....- 5.4 function appraisal (PQ -Performance Qualification) ;
.....- the formal approval that 5.5 processes affirm;
.....- 5.6 processes control and surveillance;
.....- 5.7 processes are changed and affirm afresh;
Sterilization of medical devices packs – to create a condition basically
Medical treatment is packed, solid the category that belongs to medical devices, should press medical treatment implement make undertake administrative (FDA 2 kind) ;
Accordingly, medical treatment packs production condition to should satisfy:
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- ISO Class8, 10 thousand class of GMP 10 purify a workshop. 3 kinds of medical treatment are packed, need 10 thousand class to purify manufacturing environment;
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- ISO13485 medical devices is special quality management system;
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- FDACFR820 quality runs a requirement;
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- ISO11607-2 figuration, sealed acknowledge a demand with what rig a process.
Medical – of the bag of model of paper of disinfection of sterilization of medical devices that pack is basic accordance statement
System of quality of ISO13485 medical devices " accordance attestation " ;
System of protective screen of ISO11607-1 material, asepsis and of the system that pack " accordance proves " ;
ISO11607-2 figuration, sealed with what rig a process " effectiveness affirms a proof " ;
EN868-2 ～ 10 wait for sterilization medical devices to pack material and system " the test and verify of relevant section proves " ;
Of the biology assess of ISO10993 medical devices " security proves " ;
94/62/EC is packed and pack flotsam to dictate " accordance proves " ;
Of pointer of chemistry of sterilization of product of ISO11140 medical treatment " accordance proves " ;
FDA 510K registers a proof;
ISO Class 8, 10 thousand class of GMP 10 purify a workshop " accordance proves " .
Medical establishment wraps bagging with sterilization - use note
(1) before loading
1, asepsis is packed before using, the sealing that needs to be packed finally to each undertakes checking, in order to ensure only asepsis article enters asepsis area inside.
2, enter all goods inside asepsis area, should open its according to asepsis program, distribute and move, in order to hold asepsis position.
3, choice of the bag that pack
..→ basis drafts the size of sterilization appliance, choose the sterilization bag of appropriate measure;
..→ plans to pack appliance to should be loaded easily, unfavorable skip closely, should maintain all around shake a space;
..After → plans to pack appliance to load, after paper of the end end sterilization bag and velar face are amalgamative, dimension should not less than 2 inches, in order to facilitate fatigue originallies heal.
4, warning!
..In process of sterilization of high temperature vapour, sterilization bag comes off intensity can drop somewhat, have in process of sterilization of additional together with take true course repeatedly. Accordingly, if load appliance to skip too closely, bag of can potential sterilization is cruel in sterilization process the risk that leave;
(2) appliance is loaded
..Before → appliance is loaded, answer to be in at the blank of sterilization bag surface, mark sticks the information such as time of the name that drafts sterilization appliance or code, lot number, sterilization, identify in order to facilitate with date from;
..→ loads the appliance with corresponding dry cleanness sterilization bag inside;
..When → plans to if compare acuteness,install medical devices, the placement that its acuteness carries the heading that direction should carry with open the envelop is contrary, the person that use in order to ensure comes off the security in the process.
(3) close sealed
Self-given model sterilization bag
...→ uncovers what the mouth carries to leave model paper, land of the level after delaying amount to of amount to line closes bag mouth;
...When → heal, seal glue should join closely with the paper face of bag and velar face firm, seal finger of the application when closing to relapse normally rub pressing.
Heat is sealed model sterilization bag
...→ is sealed to heat model sterilization bag, the demand that should press ISO11607 undertakes sealing adding up to the test and verify of parameter, add up to parameter in order to decide first-rate is sealed.
...Card of → come true ensures the requirement that seals the result that combine to accord with EN868-5.
...→ this medical the condition that the sterilization bag that pack acknowledges according to IS011607 effectiveness, the proposal seals add up to parameter to be:
...→ is sealed add up to temperature 168-188, add up to pressure 0.45-0.65kpa, add up to time 0.8-1.5s.
...Explain: Temperature is higher, time should be jumped over short, pressure should be jumped over small;
.......
Corresponding, temperature is lower, pressure should be jumped over big, time should grow more.
.......
Above is sealed add up to temperature to be temperature of very hot knife.
.......
Different equipment, its character is met somewhat difference, the proposal undertakes to the function of equipment effectiveness affirms, here base
.......
Parameter closes to undertake effectiveness affirms to sealing on plinth, undertake regularly periodic affirm, seal the security that close in order to ensure.
Warning!
...→ is self-given model when paper model bag is self-given, prohibit sealing add up to an area to produce drape or did not stick solid phenomenon, in order to prevent block bacterium be no longer in force!
...→ heat is sealed model when sterilization bag heat is sealed, prohibit sealing add up to drape or seal close come off force slants small phenomenon, in order to prevent block bacterium be no longer in force!
Keep in storage:
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The appliance after → sterilization suggests to be used instantly, if although use,cannot stand, should press keep in storage at shady and cool, dry, ventilated, in the environment that does not have caustic gas.
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→ is ensure first-rate sterilization effect, the appliance after proposal vapour sterilization, suggest to be used inside 6 months, the appliance after ETO sterilization, suggest to be used inside 24 months.
Warning!
..Sterilization bag should be checked before → appliance is loaded whether damaged, if have damaged, taboo!
..When → loads appliance, should take care treat sb without proper respect, prevent sterilization bag body or seal loiter combining a division broken, expose, if have crack, taboo!
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