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  lg m67k, lp m67k hyper mini topled ? hyper-bright low current led non-rohs compliant version of product will be discontinued acc. to os-pd-2005-005. the product itself will remain within rohs compliant version. 2005-04-05 1 besondere merkmale ? geh?usetyp: wei?es smt-geh?use, farbloser klarer verguss  besonderheit des bauteils: kleine bauform 2,3 mm x 1,3 mm x 1,4 mm  wellenl?nge: 570 nm (grn), 560 nm (pure green)  abstrahlwinkel: lambertscher strahler (120)  technologie: ingaalp  optischer wirkungsgrad: 4 lm/w (grn), 1,2 lm/w (pure green)  gruppierungsparameter: lichtst?rke, wellenl?nge  verarbeitungsmethode: fr alle smt-bestcktechniken geeignet  l?tmethode: ir reflow l?ten und wellenl?ten (ttw)  vorbehandlung: nach jedec level 2  gurtung: 8-mm gurt mit 3000/rolle, ?180 mm oder 12000/rolle, ?330 mm  esd-festigkeit: esd-sicher bis 2 kv nach jesd22-a114-b anwendungen  informationsanzeigen im innen- und au?enbereich  optischer indikator  einkopplung in lichtleiter  hinterleuchtung (z. b. lcd, schalter, tasten usw. in display- und werbebeleuchtung, telekommunikation, wei?er ware, allgemeinbeleuchtung)  innenbeleuchtung im automobilbereich (z.b. instrumentenbeleuchtung)  signal- und symbolleuchten features  package: white smt package, colorless clear resin  feature of the device: small package 2.3 mm x 1.3 mm x 1.4 mm  wavelength: 570 nm (green), 560 nm (pure green)  viewing angle: lambertian emitter (120)  technology: ingaalp  optical efficiency: 4 lm/w (green), 1.2 lm/w (pure green)  grouping parameter: luminous intensity, wavelength  assembly methods: suitable for all smt assembly methods  soldering methods: ir reflow soldering and ttw soldering  preconditioning: acc. to jedec level 2  taping: 8 mm tape with 3000/reel, ?180 mm or 12000/reel, ?330 mm  esd-withstand voltage: up to 2 kv acc. to jesd22-a114-b applications  indoor and outdoor displays  optical indicators  coupling into light guides  backlighting (e.g. lcd, switches, keys etc. in displays, illuminated advertising, telecommunication, white goods, general lighting)  interior automotive lighting (e.g. dashboard backlighting)  signal and symbol luminaire
2005-04-05 2 lg m67k, lp m67k anm.: - 24 gesamter farbbereich, lieferung in einzelgruppen (siehe seite 5 ) - 25 gesamter farbbereich, lieferung in einzelgruppen (siehe seite 5 ) note: - 24 total color tolerance range, delivery in single groups (see page 5 ) - 25 total color tolerance range, delivery in single groups (see page 5 ) bestellinformation ordering information typ type emissions- farbe color of emission lichtst?rke 1) seite 15 luminous intensity 1) page 15 i f = 2 ma i v (mcd) lichtstrom 2) seite 15 luminous flux 2) page 15 i f = 2 ma v (mlm) bestellnummer ordering code lg m67k-g2j1-24 lg m67k-h2k1-24 green 2.24 ... 5.60 3.55 ... 9.00 11 (typ.) 18 (typ.) q65110a1563 q65110a1564 lp m67k-d2e2-25 lp m67k-e2g1-25 pure green 0.56 ... 1.12 0.90 ... 2.24 2.5 (typ.) 4.7 (typ.) q65110a0532 q65110a0533 vergleichstabelle fr 10 ma correllation table for 10 ma typ type i f = 2 ma emissions- farbe color of emission lichtst?rke 1) seite 15 luminous intensity 1) page 15 i f = 2 ma i v (mcd) lichtst?rke 1) seite 15 luminous intensity 1) page 15 i f = 10 ma i v (mcd) lichtstrom 2) seite 15 luminous flux 2) page 15 i f = 10 ma v (mlm) lg m67k-g2j1-24 lg m67k-h2k1-24 green 2.24 ... 5.60 3.55 ... 9.00 25 (typ.) 40 (typ. 75 (typ.) 120 (typ. lp m67k-d2e2-25 lp m67k-e2g1-25 pure green 0.56 ... 1.12 0.90 ... 2.24 5 (typ.) 10 (typ.) 15 (typ.) 30 (typ.) siehe auch grafik auch seite 7 / see also graph on page 7 ? ?
lg m67k, lp m67k 2005-04-05 3 grenzwerte maximum ratings bezeichnung parameter symbol symbol wert value einheit unit betriebstemperatur operating temperature range t op ? 40 ? + 100 c lagertemperatur storage temperature range t stg ? 40 ? + 100 c sperrschichttemperatur junction temperature t j + 125 c durchlassstrom forward current ( t a =25c) i f 20 ma sto?strom surge current t 10 s, d = 0.005, t a =25c i fm 100 ma sperrspannung 3) seite 15 reverse voltage 3) page 15 ( t a =25c) v r 12 v leistungsaufnahme power consumption ( t a =25c) p tot 40 mw w?rmewiderstand thermal resistance sperrschicht/umgebung 4) seite 15 junction/ambient 4) page 15 sperrschicht/l?tpad junction/soldering point r th ja r th js 530 280 k/w k/w
2005-04-05 4 lg m67k, lp m67k kennwerte characteristics ( t a = 25 c) bezeichnung parameter symbol symbol werte value einheit unit lg lp wellenl?nge des emittierten lichtes (typ.) wavelength at peak emission i f = 2 ma peak 572 562 nm dominantwellenl?nge 5) seite 15 dominant wavelength 5) page 15 i f = 2 ma dom 570* ? 4/+5 560* 6 nm spektrale bandbreite bei 50 % i rel max (typ.) spectral bandwidth at 50 % i rel max i f = 2 ma ? 22 22 nm abstrahlwinkel bei 50 % i v (vollwinkel) (typ.) viewing angle at 50 % i v 2 ? 120 120 grad deg. durchlassspannung 6) seite 15 (typ.) forward voltage 6) page 15 (max.) i f = 2 ma v f v f 1.8 2.2 1.8 2.2 v v sperrstrom (typ.) reverse current (max.) v r = 12 v i r i r 0.01 10 0.01 10 a a temperaturkoeffizient von peak (typ.) temperature coefficient of peak i f = 30 ma; ?10 c t 100 c tc peak 0.11 0.10 nm/k temperaturkoeffizient von dom (typ.) temperature coefficient of dom i f = 30 ma; ?10 c t 100 c tc dom 0.10 0.10 nm/k temperaturkoeffizient von v f (typ.) temperature coefficient of v f i f = 30 ma; ?10 c t 100 c tc v ? 2.3 ? 2.5 mv/k optischer wirkungsgrad (typ.) optical efficiency i f = 2 ma opt 4 1.2 lm/w * einzelgruppen siehe seite 5 individual groups on page 5
lg m67k, lp m67k 2005-04-05 5 wellenl?ngengruppen (dominantwellenl?nge) 2) seite 15 wavelength groups (dominant wavelength) 2) page 15 gruppe group pure green green einheit unit min. max. min. max. 2 554 557 566 569 nm 3 557 560 569 572 nm 4 560 563 572 575 nm 5 563 566 nm helligkeits-gruppierungsschema brightness groups helligkeitshalbgruppe brightness half group lichtst?rke 1) seite 15 luminous intensity 1) page 15 i v (mcd) lichtstrom 2) seite 15 luminous flux 2) page 15 v (mlm) d2 e1 e2 f1 f2 g1 g2 h1 h2 j1 j2 k1 0.56 ... 0.71 0.71... 0.90 0.90 ... 1.12 1.12 ... 1.40 1.40 ... 1.80 1.80 ... 2.24 2.24 ... 2.80 2.80 ... 3.55 3,55 ... 4.50 4.50 ... 5.60 5.60 ... 7.10 7.10 ... 9.00 2.0 (typ.) 2.5 (typ.) 3.0 (typ.) 3.8 (typ.) 4.8 (typ.) 6.0 (typ.) 7.6 (typ.) 9.5 (typ.) 12.0 (typ.) 15.0 (typ.) 19.0 (typ.) 24.0 (typ.) anm.: die standardlieferform von serientypen beinhaltet eine untere bzw. obere familiengruppe. diese besteht aus 3 bzw. 4 helligkeitshalbgruppen. einzelne helligkeitshalbgruppen sind nicht bestellbar. note: the standard shipping format for serial types includes a lower or upper family group of 3 or 4 individual brightness half groups. individual brightness half groups cannot be ordered. gruppenbezeichnung auf etikett group name on label beispiel: h1-3 example: h1-3 helligkeitshalbgruppe brightness half group wellenl?nge wavelength h1 3 anm.: in einer verpackungseinheit / gurt ist immer nur eine gruppe fr jede selektion enthalten. note: no packing unit / tape ever contains more than one group for each selection.
2005-04-05 6 lg m67k, lp m67k relative spektrale emission 2) seite 15 relative spectral emission 2) page 15 v( ) = spektrale augenempfindlichkeit / standard eye response curve i rel = f ( ); t a = 25 c; i f = 2 ma abstrahlcharakteristik 2) seite 15 radiation characteristic 2) page 15 i rel = f ( ? ); t a = 25 c 40 0 400 20 60 80 rel i 100 % nm ohl00570 v 450 500 550 600 650 700 green pure-green 0 0.2 0.4 1.0 0.8 0.6 ? 1.0 0.8 0.6 0.4 0? 10? 20? 40? 30? ohl01660 50? 60? 70? 80? 90? 100? 0? 20? 40? 60? 80? 100? 120?
lg m67k, lp m67k 2005-04-05 7 durchlassstrom 2) seite 15 forward current 2) page 15 i f = f ( v f ); t a = 25 c relative lichtst?rke 2) 7) seite 15 relative luminous intensity 2) 7) page 15 i v / i v(2 ma) = f ( i f ); t a = 25 c relative lichtst?rke 2) seite 15 relative luminous intensity 2) page 15 i v / i v (25 c)= f ( t j ); i f = 2 ma v ohl00802 1.4 10 -3 10 -2 10 -1 10 0 10 1 ma 10 2 i f v f 1.6 1.8 2.0 2.2 10 10 0 ma 1 10 i f 2 ohl00801 v v (2 ma) i 10 2 i 10 -1 10 0 10 1 ohl00800 0 -60 t i v (25?c) i v -40 -20 0 20 40 60 ?c 10 0 0.5 1.0 1.5 2.0 3.0 j
lg m67k, lp m67k 2005-04-05 8 maximal zul?ssiger durchlassstrom max. permissible forward current i f = f ( t ) zul?ssige impulsbelastbarkeit i f = f ( t p ) permissible pulse handling capability duty cycle d = parameter, t a = 25 c zul?ssige impulsbelastbarkeit i f = f ( t p ) permissible pulse handling capability duty cycle d = parameter, t a = 85 c 80 ohl02444 0 02040 60 i ma f ?c t 10 0 a 5 10 15 20 25 t a t s = 0.01 0.005 0.05 0.1 0.02 0.5 0.2 10 10 0 -2 -3 -4 -5 10 10 10 1 f i a d p t = d t 2 1 0 -1 10 t p 10 s 10 ohl02442 t t p i f 0.02 0.04 0.06 0.08 0.10 0.12 = 0.01 0.005 0.05 0.1 0.02 0.5 0.2 10 10 0 -2 -3 -4 -5 10 10 10 1 f i a d p t = d t 2 1 0 -1 10 t p 10 s 10 ohl02442 t t p i f 0.02 0.04 0.06 0.08 0.10 0.12
lg m67k, lp m67k 2005-04-05 9 ma?zeichnung 8) seite 15 package outlines 8) page 15 kathodenkennung: abgeschr?gte ecke cathode mark: bevelled edge gewicht / approx. weight: 10 mg gurtung / polarit?t und lage 8) seite 15 verpackungseinheit 3000/rolle, ?180 mm oder 12000/rolle, ?330 mm method of taping / polarity and orientation 8) page 15 packing unit 3000/reel, ?180 mm or 12000/reel, ?330 mm 0.05 (0.002) 0.15 (0.006) c athode marking 2.1 (0.083) 2.3 (0.091) 2.1 (0.083) 1.9 (0.075) 0.8 (0.031) 1.5 (0.059) 1.3 (0.051) 1.0 (0.039) gply692 8 typ. 1.5 (0.059) x 1.0 (0.039) 1.2 (0.047) 1.4 (0.055) 0.71 (0.028) cathode marking 0.5 (0.020) 0.3 (0.012) light emitting area (0.43 (0.017)) a c ohay0225 1 .5 (0.059) 2 (0.079) 4 (0.157) 1.55 (0.061) 4 (0.157) 3.5 (0.138) 1.75 (0.069) 8 (0.315) 2.35 (0.093) cathode/collector side
2005-04-05 10 lg m67k, lp m67k empfohlenes l?tpaddesign 8) 9) seite 15 ir-reflow l?ten recommended solder pad 8) 9) page 15 ir reflow soldering ohlpy978 paddesign for improved heat dissipation cu-area > 16 mm cu-fl?che > 16 mm w?rmeableitung padgeometrie fr verbesserte l?tstopplack solder resist 0.8 (0.031) 2.8 (0.110) 1 (0.039) 2 2 2.8 (0.110) 0.8 (0.031) 1 (0.039)
lg m67k, lp m67k 2005-04-05 11 l?tbedingungen vorbehandlung nach jedec level 2 soldering conditions preconditioning acc. to jedec level 2 ir-reflow l?tprofil (nach ipc 9501) ir reflow soldering profile (acc. to ipc 9501) wellenl?ten (ttw) (nach cecc 00802) ttw soldering (acc. to cecc 00802) ohly0597 0 0 50 100 150 200 25 0 50 100 150 200 250 300 t t c s 240-245 c 10-40 s 183 c 120 to 180 s defined for preconditioning: up to 6 k/s ramp-down rate up to 6 k/s ramp-up rate up to 6 k/s defined for preconditioning: 2-3 k/s ohly0598 0 0 50 100 150 200 250 50 100 150 200 250 300 t t c s 235 c 10 s c ... 260 1. welle 1. wave 2. welle 2. wave 5 k/s 2 k/s ca 200 k/s cc ... 130 100 2 k/s zwangskhlung forced cooling normalkurve standard curve grenzkurven limit curves
2005-04-05 12 lg m67k, lp m67k barcode-produkt-etikett (bpl) barcode-product-label (bpl) gurtverpackung tape and reel tape dimensions in mm (inch) w p 0 p 1 p 2 d 0 e f 4 0.1 (0.157 0.004) 4 0.1 (0.157 0.004) 2 0.05 (0.079 0.002) 1.5 + 0.1 (0.059 + 0.004) 1.75 0.1 (0.069 0.004) 3.5 0.05 (0.138 0.002) reel dimensions in mm (inch) a w n min w 1 w 2 max 180 (7) 8 (0.315) 60 (2.362) 8.4 + 2 (0.331 + 0.079) 14.4 (0.567) 330 (13) 8 (0.315) 60 (2.362) 8.4 + 2 (0.331 + 0.079) 14.4 (0.567) s am ple oha0204 3 x - x - x (g) group: lot number (1t) lot no: (9d) d/c: date code (x) prod no: product code (6p) batch no: batch number lx xxxx product name bin1: bin information color 1 bin2: bin3: ml 2 temp st 245 c r 260 c t 2 additional text r077 demy packvar: packing type product quantity per reel (q)qty: semiconductors osram opto wavelength rank forward voltage rank brightness rank bar code bar code bar code d 0 2 p p 0 1 p w fe direction of unreeling n w 1 2 w a ohay0324 label gurtvorlauf: leader: trailer: gurtende: 13.0 direction of unreeling 0.25 160 mm 160 mm 400 mm 400 mm 8 + 0.3 ? 0.1
lg m67k, lp m67k 2005-04-05 13 trockenverpackung und materialien dry packing process and materials anm.: feuchteempfindliche produkte sind verpackt in einem trockenbeutel zusammen mit einem trockenmittel und einer feuchteindikatorkarte bezglich trockenverpackung finden sie weitere hinweise im internet und in unserem short form catalog im kapitel ?gurtung und verpackung? unter dem punkt ?trockenverpackung?. hier sind normenbezge, unter anderem ein auszug der jedec-norm, enthalten. note: moisture-senisitve product is packed in a dry bag containing desiccant and a humidity card. regarding dry pack you will find further information in the internet and in the short form catalog in chapter ?tape and reel? under the topic ?dry pack?. here you will also find the normative references like jedec. kartonverpackung und materialien transportation packing and materials oha00539 osram moisture-sensitive label or print barcode label desiccant humidity indicator barcode lab el osram please check the hic immidiately after bag opening. discard if circles overrun. avoid metal contact. wet do not eat. comparator check dot parts still adequately dry. examine units, if necessary examine units, if necessary 5% 15% 10% bake units bake units if wet, change desiccant if wet, humidity indicator mil-i-8835 if wet, m o istu re lev e l 3 flo or ti m e 1 68 hours moi st ure le vel 6 flo o r ti me 6 h o ur s a) humidi t y i nd ica t or c ar d i s > 1 0 % when rea d at 23 ? c 5 ?c , or r ef l ow, vap or -p h ase reflow, or eq ui va l ent p r oces si ng (peak pa c k age 2 . aft e r t h is bag is op ene d, devices th at w i ll b e subject e d to inf r ared 1. s he lf l i fe in seal e d b a g: 24 mon th s at < 40 ? c a nd < 90 % r el ati v e h um idi t y (r h ) . mois t ur e l ev el 5a at fa ct or y conditions of (if b l a nk , seal d ate i s i d entical w i th date c ode). a ) m o unted w it h in b) sto r ed at bo dy t emp. 3. d ev i ces re q uire ba ki ng , bef ore mo unt ing, i f : b ag sea l d ate m o ist u re lev e l 1 m oist ur e level 2 mo i s ture l e vel 2 a 4. i f b aki n g is re q uire d, b) 2 a or 2b i s not m e t. dat e and tim e op ened: refere nc e i pc / jedec j - std-033 for b ake p r ocedu r e. floo r t i m e s ee be l ow i f bl an k, se e ba r cod e labe l flo or ti m e > 1 ye ar f l o o r t ime 1 yea r f l o o r time 4 w e eks 1 0 % r h . _ < moi st ure l ev el 4 m oi stur e l evel 5 ?c ). opt o sem iconductors m oisture sensi tive thi s bag contai ns caution flo or t i m e 72 h o urs fl o or time 4 8 h ou r s flo or ti m e 2 4 h our s 30 ?c / 60% rh . _ < l evel i f b l a nk , see ba r c o de l a b el oha02044 packvar: r077 additional text p-1+q-1 multi topled muster osram opto semiconductors (6p) batch no: (x) prod no: 1 0 (9d) d/c: 1 1 (1t) lot no: 210021998 123gh1234 0 2 45 (q)qty: 2000 0144 (g) group: 260 c rt 240 c r 3 220 c r ml bin3: bin2: q-1-20 bin1: p-1-20 lsy t676 2 2a temp st r18 demy packvar: r077 additional text p-1+q-1 multi topled muster osram opto semiconductors (6p) batch no: (x) prod no: 1 0 (9d) d/c: 1 1 (1t) lot no: 210021998 123gh1234 0 2 45 (q)qty: 2000 0144 (g) group: 260 c rt 240 c r 3 220 c r ml bin3: bin2: q-1-20 bin1: p-1-20 lsy t676 2 2a temp st r18 demy osram barcode label packing sealing label barcode lab el moisture level 3 floor time 168 hours moisture level 6 floor time 6 hours a) humidity indicator card is > 10% when read at 23 ?c 5 ?c, or reflow, vapor-phase reflow, or equivalent processing (peak package 2. after this bag is opened, devices that will be subjected to infrared 1. shelf life in sealed bag: 24 months at < 40 ?c and < 90% relative humidity (rh). moisture level 5a at factory conditions of (if blank, seal date is identical with date code). a) mounted within b) stored at body temp. 3. devices require baking, before mounting, if: bag seal date moisture level 1 moisture level 2 moisture level 2a 4. if baking is required, b) 2a or 2b is not met. date and time opened: reference ipc/jedec j-std-033 for bake procedure. floor time see below if blank, see bar code label floor time > 1 year floor time 1 year floor time 4 weeks 10% rh. _ < moisture level 4 moisture level 5 ?c). opto semiconductors moisture sensitive this bag contains caution floor time 72 hours floor time 48 hours floor time 24 hours 30 ?c/60% rh. _ < level if blank, see bar code label
2005-04-05 14 lg m67k, lp m67k attention please! the information describes the type of component and shall not be considered as assured characteristics. terms of delivery and rights to change design reserved. due to technical requirements components may contain dangerous substances. for information on the types in question please contact our sales organization. if printed or downloaded, please find the latest version in the internet. packing please use the recycling operators known to you. we can also help you ? get in touch with your nearest sales office. by agreement we will take packing material back, if it is sorted. you must bear the costs of transport. for packing material that is returned to us unsorted or which we are not obliged to accept, we shall have to invoice you for any costs incurred. components used in life-support devices or systems must be expressly authorized for such purpose! critical components 10) page 15 may only be used in life-support devices or systems 11) page 15 with the express written approval of osram os. revision history: 2005-04-05 previous version: 2004-10-11 page subjects (major changes since last revision) date of change 2 correllation table 2003-04-03 1 esd norm 2003-09-04 3 ambient temperature 2003-09-04 all new template 2004-01-21 8 new pulse diagrams (ohl00827=>ohl02442, ohl00828=>ohl02442) 2004-08-11 8 new diagram max. perm. forward current (ohl00429=>ohl02444) 2004-08-11 all discontinuation of non-rohs compliant product versions 2005-04-05
lg m67k, lp m67k 2005-04-05 15 fu?noten: 1) helligkeitswerte werden mit einer stromeinpr?gedauer von 25 ms und einer genauigkeit von 11% ermittelt. 2) wegen der besonderen prozessbedingungen bei der herstellung von led k?nnen typische oder abgeleitete technische parameter nur aufgrund statistischer werte wiedergegeben werden. diese stimmen nicht notwendigerweise mit den werten jedes einzelnen produktes berein, dessen werte sich von typischen und abgeleiteten werten oder typischen kennlinien unterscheiden k?nnen. falls erforderlich, z.b. aufgrund technischer verbesserungen, werden diese typischen werte ohne weitere ankndigung ge?ndert. 3) die led kann kurzzeitig in sperrichtung betrieben werden. 4) r thja ergibt sich bei montage auf pc-board fr 4 (padgr??e 5 mm 2 je pad) 5) wellenl?ngen werden mit einer stromeinpr?gedauer von 25 ms und einer genauigkeit von 1 nm ermittelt. 6) spannungswerte werden mit einer stromeinpr?gedauer von 1 ms und einer genauigkeit von 0,1 v ermittelt. 7) im gestrichelten bereich der kennlinien muss mit erh?hten helligkeitsunterschieden zwischen leuchtdioden innerhalb einer verpackungseinheit gerechnet werden 8) ma?e werden wie folgt angegeben: mm (inch) 9) geh?use h?lt ttw-l?thitze aus 10) ein kritisches bauteil ist ein bauteil, das in lebenserhaltenden apparaten oder systemen eingesetzt wird und dessen defekt voraussichtlich zu einer fehlfunktion dieses lebenserhaltenden apparates oder systems fhren wird oder die sicherheit oder effektivit?t dieses apparates oder systems beeintr?chtigt. 11) lebenserhaltende apparate oder systeme sind fr (a) die implantierung in den menschlichen k?rper oder (b) fr die lebenserhaltung bestimmt. falls sie versagen, kann davon ausgegangen werden, dass die gesundheit und das leben des patienten in gefahr ist. published by osram opto semiconductors gmbh wernerwerkstrasse 2, d-93049 regensburg www.osram-os.com ? all rights reserved. remarks: 1) brightness groups are tested at a current pulse duration of 25 ms and a tolerance of 11%. 2) due to the special conditions of the manufacturing processes of led, the typical data or calculated correlations of technical parameters can only reflect statistical figures. these do not necessarily correspond to the actual parameters of each single product, which could differ from the typical data and calculated correlations or the typical characteristic line. if requested, e.g. because of technical improvements, these typ. data will be changed without any further notice. 3) driving the led in reverse direction is suitable for short term application. 4) r thja results from mounting on pc board fr 4 (pad size 5 mm 2 per pad) 5) wavelengths are tested at a current pulse duration of 25 ms and a tolerance of 1 nm. 6) forward voltages are tested at a current pulse duration of 1 ms and a tolerance of 0.1 v. 7) in the range where the line of the graph is broken, you must expect higher brightness differences between single leds within one packing unit. 8) dimensions are specified as follows: mm (inch) 9) package able to withstand ttw-soldering heat 10) a critical component is a component used in a life-support device or system whose failure can reasonably be expected to cause the failure of that life-support device or system, or to affect its safety or the effectiveness of that device or system. 11) life support devices or systems are intended (a) to be implanted in the human body, or (b) to support and/or maintain and sustain human life. if they fail, it is reasonable to assume that the health and the life of the user may be endangered.


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